Medical Devices
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October 2012 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD October 2012 DEVICE: INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM MEDELA AG 510(k) NO: K113678(TRADITIONAL) ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023 W324S3649 COUNTY ROAD E SE DECISION MADE: 01-OCT-12 DOUSMAN WI 53118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERF ABLATION SYSTEM SERF ABLATION NEEDLE THERMEDICAL 510(k) NO: K120116(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 01-OCT-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVATION LPI PRIME FEMORAL STEM EXACTECH, INC. 510(k) NO: K121684(TRADITIONAL) ATTN: VLADISLAVA ZAITSEVA PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 01-OCT-12 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLSTICE CROSS CONNECTOR LIFE SPINE 510(k) NO: K120998(SPECIAL) ATTN: RANDY LEWIS PHONE NO : 847 884 6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 01-OCT-12 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFT PROXIMAL HUMERUS FRACTURE PLATE SHOULDER OPTIONS, INC. 510(k) NO: K121672(TRADITIONAL) ATTN: JOHN KAPITAN PHONE NO : 704 512 0000 100 E. SOUTH MAIN ST. P.O. BOX 145SE DECISION MADE: 01-OCT-12 WAXHAW NC 28173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDICATH COMPACT SET (12/18 FR) COLOPLAST A/S 510(k) NO: K121458(TRADITIONAL) ATTN: BRIAN SCHMIDT PHONE NO : 612 302 4987 1601 WEST RIVER ROAD NORTH SE DECISION MADE: 01-OCT-12 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH ETHICON ENDO-SURGERY, LLC 510(k) NO: K122511(TRADITIONAL) ATTN: EMILY KRUETZKAMP PHONE NO : 513 337 1546 4545 CREEK ROAD SE DECISION MADE: 01-OCT-12 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXSOS DISTAL LATERAL FEMUR TS LONG PLATES HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K122308(SPECIAL) ATTN: STEPHANIE M FITTS PHONE NO : 201 831 5405 325 CORPORATE DRIVE SE DECISION MADE: 01-OCT-12 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K121425(TRADITIONAL) ATTN: SAMIR IBRAHIM PHONE NO : 901 867 9971 5677 AIRLINE RD. SE DECISION MADE: 01-OCT-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM ULRICH GMBH & CO. KG 510(k) NO: K120891(TRADITIONAL) ATTN: HANS STOVER PHONE NO : 636 519 0268 612 TRADE CENTER BLVD SE DECISION MADE: 01-OCT-12 CHESTERFIELD MO 63005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERE STABILIZATION SYSTEM GLOBUS MEDICAL INC. 510(k) NO: K122226(SPECIAL) ATTN: MERIAM YOUSSEF PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 01-OCT-12 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTLUX MEDMIX CO., LTD 510(k) NO: K120460(TRADITIONAL) ATTN: PETER CHUNG PHONE NO : 412 684 3976 300 ATWOOD SE DECISION MADE: 01-OCT-12 PITTSBURGH PA 15213 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K120148(TRADITIONAL) ATTN: JULIE GLENDRANGE PHONE NO : 310 533 9966 386 Beech Ave. Unit B6 SE DECISION MADE: 02-OCT-12 TORRANCE CA 90501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED DEPUY MITEK INC., A JOHNSON AND JO510(k) NO: K122123(TRADITIONAL) ATTN: JULIE VAFIDES PHONE NO : 508 977 6645 325 PARAMOUNT DRIVE SE DECISION MADE: 02-OCT-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDICATH COMPACT SET (12 FR) COLOPLAST CORP. 510(k) NO: K121457(TRADITIONAL) ATTN: BRIAN SCHMIDT PHONE NO : 612 302 4987 1601 WEST RIVER RD NORTH SE DECISION MADE: 02-OCT-12 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESON NASAL MASK FISHER & PAYKEL HEALTHCARE LIMITED510(k) NO: K121597(TRADITIONAL) ATTN: JAMES THOMPSON PHONE NO : 64 9574 0123 15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 02-OCT-12 AUCKLAND NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET APPLIED MEDICAL 510(k) NO: K122619(TRADITIONAL) ATTN: JESSICA CHO PHONE NO : 949 713 8470 22872 AVENIDA EMPRESA SE DECISION MADE: 02-OCT-12 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIGA TOXIN CHEK TECHLAB INC., CORPORATE RESEARCH C510(k) NO: K121411(TRADITIONAL) ATTN: DONNA T LINK PHONE NO : 540 953 1664 2001 KRAFT DR. SE DECISION MADE: 02-OCT-12 BLACKSBURG VA 24060 6358 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIGA TOXIN QUIK CHEK TECHLAB INC., CORPORATE RESEARCH C510(k) NO: K121364(TRADITIONAL) ATTN: DONNA T LINK PHONE NO : 540 953 1664 2001 KRAFT DR. SE DECISION MADE: 02-OCT-12 BLACKSBURG VA 24060 6358 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING PENUMBRA, INC. 510(k) NO: K122756(SPECIAL) ATTN: SETH SCHULMAN PHONE NO : 510 748 3247 1351 Harbor Bay Parkway SE DECISION MADE: 02-OCT-12 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K122133(SPECIAL) ATTN: PHONE NO : 335 E. SONTERRA BLVD. SUITE 200 SE DECISION MADE: 02-OCT-12 SAN ANTONIO TX 78258 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ULTHERA SYSTEM ULTHERA, INC. 510(k) NO: K121700(TRADITIONAL) ATTN: SUZON LOMMEL PHONE NO : 480 619 4069 2150 South Country Club Drive SuitSE DECISION MADE: 02-OCT-12 Mesa AZ 85210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIRAFFE AND PANDA WARMERS OHMEDA MEDICAL, A DIVISION OF DATE510(k) NO: K122267(SPECIAL) ATTN: AGATA ANTHONY PHONE NO : 410 888 5200 8880 GORMAN RD. SE DECISION MADE: 02-OCT-12 LAUREL MD 20723 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOFIX SCREW BONAFIX SURGICAL AND DENTAL IMPLAN510(k) NO: K113650(TRADITIONAL) ATTN: JUAN TEZAK PHONE NO : 561 789 2411 118 W. PRIVE CR. SE DECISION MADE: 03-OCT-12 DELRAY TEZAK FL 33445 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 ADVANCED STERILIZATION PRODUCTS 510(k) NO: K111518(TRADITIONAL) ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DR. SE DECISION MADE: 03-OCT-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 ADVANCED STERILIZATION PRODUCTS 510(k) NO: K111519(TRADITIONAL) ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DR. SE DECISION MADE: 03-OCT-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIRVANA B PERSONAL LUBRICANT CHURCH & DWIGHT CO., INC. 510(k) NO: K120751(TRADITIONAL) ATTN: EMILY PEREZ PHONE NO : 609 688 5347 469 NORTH HARRISON STREET SE DECISION MADE: 03-OCT-12 PRINCETON NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II ELITECHGROUP 510(k) NO: K122858(TRADITIONAL) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 03-OCT-12 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGAFIX INTERFERENCE SCREW SBM SCIENCES FOR BIO MATERIALS 510(k) NO: K122228(SPECIAL) ATTN: DENIS CLEMENT PHONE NO : 335 624 22101 ZI DU MONGE SE DECISION MADE: 03-OCT-12 LOURDES FR 65100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HT-WEDGE D.T. DAVIS ENTERPRISES LTD. T/A HO510(k) NO: K121287(TRADITIONAL) ATTN: SUSAN PAVELKO PHONE NO : 610 694 9600 513 SOUTH CLEWELL STREET SE DECISION MADE: 03-OCT-12 BETHLEHEM PA 18015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS MITSUBISHI HEAVY INDUSTRIES, LTD. 510(k) NO: K122450(TRADITIONAL) ATTN: YOICHI WAKIYAMA PHONE NO : 818 229 12135 4-6-22 KAN-ON-SHIN-MACHI NISHI-KU SE DECISION MADE: 03-OCT-12 HIROSHIMA-SHI JA 733-8553 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMINUS FOSSA SPECIFIC PLATE SYSTEM SKELETAL DYNAMICS, LLC 510(k) NO: K122737(SPECIAL) ATTN: ANA M ESCAGEDO PHONE NO : 305 596 7585 8905 SW 87 AVENUE, SUITE 201 SE DECISION MADE: 03-OCT-12 MIAMI FL 33176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K122599(TRADITIONAL) ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVE. SE DECISION MADE: 03-OCT-12 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER PANASONIC HEALTHCARE CO., LTD. 510(k) NO: K122009(TRADITIONAL) ATTN: RAM BEDI PHONE NO : 425 985 8670 2425 SQUAK MOUNTAIN LOOP SW SE DECISION MADE: 03-OCT-12 ISSAQUAH WA 98027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K120125(TRADITIONAL) ATTN: ROBIN MARTIN PHONE NO : 414 336 9228 8200 WEST TOWER AVE. SE DECISION MADE: 03-OCT-12 Milwaukee WI 53223 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EK DELIVERY DEVICE TDAK MEDICAL, INC 510(k) NO: K121579(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 03-OCT-12 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTBUILDER SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K120951(TRADITIONAL) ATTN: PATRICK LIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DR. SE DECISION MADE: 03-OCT-12 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIQ S7 EXPERT, LOGIQ S7 PRO GE HEALTHCARE 510(k) NO: K122114(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 03-OCT-12 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K122862(SPECIAL) ATTN: CHRIS MCKEE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 03-OCT-12 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET PROFIT POINT MANUFACTURING SDN BHD510(k) NO: K120110(TRADITIONAL) ATTN: ROBERT HILL PHONE NO : 607 787 9786 LOT PTD 27735 (PLO 9) 26624 (PLO 1SE DECISION MADE: 04-OCT-12 KLUANG MY 86000 510(k) STATEMENT DEVICE: ACTIVE SCREW BONE SCREW INTELLIGENT IMPLANT SYSTEMS, LLC 510(k) NO: K121682(TRADITIONAL) ATTN: MICHAEL J NUTT PHONE NO : 704 424 1009 3300 INTERNATIONAL AIRPORT DRIVE SSE DECISION MADE: 04-OCT-12 CHARLOTTE NC 28208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM KJ MEDITECH CO., LTD 510(k) NO: K121047(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 04-OCT-12 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS 510(k) NO: K122044(SPECIAL) ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DRIVE SE DECISION MADE: 04-OCT-12 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIXJECT WITH SPRAY HEAD MEDIMOP MEDICAL PROJECTS, LTD. 510(k) NO: K122023(TRADITIONAL) ATTN: LLANIT GOLDGRABER PHONE NO : 972 977 57122 17 HATIDHAR ST. SE DECISION MADE: 04-OCT-12 RAANANA IS 43665 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIRVANA A PERSONAL LUBRICANT CHURCH & DWIGHT CO., INC. 510(k) NO: K120706(TRADITIONAL) ATTN: EMILY PEREZ PHONE NO : 609 688 5347 469 NORTH HARRISON STREET SE DECISION MADE: 04-OCT-12 PRINCETON NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE SPINEART 510(k) NO: K122366(SPECIAL) ATTN: FRANK PENNESI PHONE NO : 412 279 94025 COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 04-OCT-12 GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD 510(k) NO: K122231(SPECIAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N PUENTE ST. UNIT B SE DECISION MADE: 04-OCT-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINISPIR MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K122384(SPECIAL) ATTN: GERDA VAN HOUTS PHONE NO : 390 622 754777 VIA DEL MAGGIOLINO 125 SE DECISION MADE: 04-OCT-12 ROMA IT 00155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z-MED Z-MED II NUMED, INC. 510(k) NO: K122012(TRADITIONAL) ATTN: NICHELLE LAFLESH PHONE NO : 315 328 4491 2880 MAIN ST. SE DECISION MADE: 04-OCT-12 HOPKINTON NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALAMO T ALLIANCE PARTNERS, LLC 510(k) NO: K120401(TRADITIONAL) ATTN: JENNIFER PALINCHIK PHONE NO : 440 933 8850 33490 PIN OAK PARKWAY SE DECISION MADE: 05-OCT-12 AVON LAKE OH 44012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BTL ELITE BTL INDUSTRIES, INC 510(k) NO: K120093(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919 363 2432 16 APPLETON STREET SE DECISION MADE: 05-OCT-12 WALTHAM MA 02453 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED SURGICAL ELECTRIC INSTRUMENT STERILMED, INC. 510(k) NO: K120040(TRADITIONAL) ATTN: JASON SKRAMSTED PHONE NO : 763 488 3483 11400 73RD AVE. NORTH, No. 100 SE DECISION MADE: 05-OCT-12 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW RADIOPAQUE TRIAL NECKS SMITH & NEPHEW, INC. 510(k) NO: K113039(TRADITIONAL) ATTN: NATALIE P WILLIAMS PHONE NO : 901 399 5161 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 05-OCT-12 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPOC CHLORIDE TEST AND EPOC CREATININE TEST EPOCAL, INC. 510(k) NO: K113726(TRADITIONAL) ATTN: ROY LAYER PHONE NO : 613 738 6192 2060 WALKLEY RD. SE DECISION MADE: 05-OCT-12 OTTAWA, ONTARIO CA K1G-3P5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENCOX II STEM, BENCOX METAL HEAD CORENTEC CO., LTD 510(k) NO: K122099(SPECIAL) ATTN: J.S. DANIEL PHONE NO : 82 07 43933819 11TH CHUNGHO TOWER, 748-1 BANPO 1 SE DECISION MADE: 05-OCT-12 SEOCHO GU, SEOUL KS 137-040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLE T NASAL MASK RESPIRONICS, INC. 510(k) NO: K121631(SPECIAL) ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146 1001 MURRY RIDGE LN. SE DECISION MADE: 05-OCT-12 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TBS INSIGHT MEDIMAPS GROUP SA 510(k) NO: K121716(TRADITIONAL) ATTN: CHRISTOPHE LELONG PHONE NO : 41 22 8848644 18 CHEMIN DES AULX SE DECISION MADE: 05-OCT-12 PLAN LES OUATES SZ 1228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MD211G3 21.3" DIAGNOSTIC IMAGING LCD MONITOR PRODIGY TECHNOLOGY CONSULTANT CO.,510(k) NO: K122843(TRADITIONAL) ATTN: ANGUS HSU PHONE NO : 886 22 6037288 1F, NO. 181, SEC 2, WUNHUA 1ST RD.SE DECISION MADE: 05-OCT-12 TAIPEI TW 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PORTA 100HF JOB CORPORATION 510(k) NO: K122697(TRADITIONAL) ATTN: TAKAHIRO HARUYAMA PHONE NO : 424 247 9447 1411 W. 190TH STREET SUITE 120 SE DECISION MADE: 05-OCT-12 GARDENA CA 92048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K120499(TRADITIONAL) ATTN: MARGARET MARSH PHONE NO : 210 255 6481 6203 FARINON DRIVE SE DECISION MADE: 05-OCT-12 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C1-6-D ULTRASOUND TRANSDUCER GE HEALTHCARE 510(k) NO: K122921(SPECIAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 W INNOVATION DRIVE SE DECISION MADE: 05-OCT-12 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DFP4343C7 MDI CONSULTANTS, INC. 510(k) NO: K122589(TRADITIONAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BOULEVARD SUITE 200 SE DECISION MADE: 05-OCT-12 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGER SPINE SYSTEM CORELINK LLC 510(k) NO: K121728(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 05-OCT-12 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K122757(TRADITIONAL) ATTN: HYMAN KATZ, PH.D. PHONE NO : 973 852 0158 4 HENDERSON DRIVE SE DECISION MADE: 05-OCT-12 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CVUE ADVANCED HYDRA VUE UNILENS CORP., USA 510(k) NO: K121652(TRADITIONAL) ATTN: ALAN J FRAZER PHONE NO : 727 544 2531 10431 72ND ST. NORTH SE DECISION MADE: 05-OCT-12 LARGO FL 33777 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORIN TRIFIT TS HIP CORIN USA 510(k) NO: K121563(TRADITIONAL) ATTN: LUCINDA GERBER PHONE NO : 813 977 4469 10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 05-OCT-12 TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) VILEX, INC. 510(k) NO: K112837(TRADITIONAL) ATTN: SYLVIA SOUTHARD PHONE NO : 931 474 7550 111 MOFFITT STREET SE DECISION MADE: 09-OCT-12 MCMINNVILLE TN 37110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T COVIDIEN 510(k) NO: K122531(SPECIAL) ATTN: TED KUHN PHONE NO : 303 305 2272 6135 GUNBARREL AVE. SE DECISION MADE: 09-OCT-12 BOULDER CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMSTAR SE RESPIRONICS, INC. 510(k) NO: K122769(SPECIAL) ATTN: FRANK KADI PHONE NO : 724 387 4134 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 09-OCT-12 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSS-OVER ACETABULAR SHELL & LINER STELKAST COMPANY 510(k) NO: K122773(SPECIAL) ATTN: DAVID STUMPO PHONE NO : 724 731 2208 200 HIDDEN VALLEY RD. SE DECISION MADE: 09-OCT-12 MCMURRAY PA 15317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXCESS SOFT TIP WIRE GUIDE WILSON-COOK MEDICAL INC. 510(k) NO: K122816(SPECIAL) ATTN: DORIS A HAWKS PHONE NO : 336 744 0157 4900 Bethania Station Rd SE DECISION MADE: 09-OCT-12 Winston Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADREX-I, SW V4.00 MODEL DRAD-3000E TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K122842(SPECIAL) ATTN: CHARLEMAGNE CHUA PHONE NO : 714 669 7896 2441 MICHELLE DR. SE DECISION MADE: 09-OCT-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXTRA TI HAMMERTOE CORRECTION SYSTEM NEXTREMITY SOLUTIONS, LLC 510(k) NO: K122031(TRADITIONAL) ATTN: ARTHUR A ALFARO PHONE NO : 732 683 9304 167 Stone Hill Rd. SE DECISION MADE: 09-OCT-12 Colts Neck NJ 07722 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERNER FETALINK+(VERSION1.0) CERNER CORP. 510(k) NO: K121758(TRADITIONAL) ATTN: SHELLEY S LOOBY PHONE NO : 816 201 1368 10234 MARION PARK DRIVE SE DECISION MADE: 09-OCT-12 KANSAS CITY MO 64137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIGHTGLASS BRIGHTGLASS M KTK MEDICAL SUPPLIES GMBH 510(k) NO: K122025(TRADITIONAL) ATTN: THOMAS LOTTERMOSER PHONE NO : 498 984 079721 INDUSTRIESTR. 16 SE DECISION MADE: 09-OCT-12 GERMERING GM D-821110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K121076(TRADITIONAL) ATTN: CHARLEMAGNE CHUA PHONE NO : 714 669 7896 2441 MICHELLE DR. SE DECISION MADE: 09-OCT-12 TUSTIN CA 92781 2068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH UNITED ORTHOPEDIC CORPORATION 510(k) NO: K122504(SPECIAL) ATTN: FANG-YUAN HO PHONE NO : 886 357 73351 NO 57, PARK AVE 2, SCIENCE PARK SE DECISION MADE: 10-OCT-12 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE SUI SLING BOSTON SCIENTIFIC CORP. 510(k) NO: K121754(TRADITIONAL) ATTN: JANET A MCGRATH PHONE NO : 508 683 4726 100 BOSTON SCIENTIFIC WAY M21 SE DECISION MADE: 10-OCT-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WECK REUSABLE OBTURATOR TELEFLEX MEDICAL, INC. 510(k) NO: K121796(TRADITIONAL) ATTN: HOLLY KORNEGAY PHONE NO : 919 433 4918 2917 WECK DR. SE DECISION MADE: 11-OCT-12 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA LOMA VISTA MEDICAL 510(k) NO: K121083(TRADITIONAL) ATTN: TIFFINI DIAGE PHONE NO : 707 799 6732 1307 SOUTH MARY AVE, STE 280 SE DECISION MADE: 11-OCT-12 SUNNYVALE CA 94087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS ZIMMER, INC. 510(k) NO: K121543(TRADITIONAL) ATTN: ANTHONY FRANCALANCIA PHONE NO : P.O. BOX 708 SE DECISION MADE: 11-OCT-12 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS 510(k) NO: K121679(TRADITIONAL) ATTN: MIKE FLIS PHONE NO : 317 521 2100 9115 HAGUE ROAD SE DECISION MADE: 11-OCT-12 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIRELESS THERMOMETER RALING MEDICAL COMPANY 510(k) NO: K121696(TRADITIONAL) ATTN: WU WEI PHONE NO : 861 064 118658 NO. 11, HUATONG RD SE DECISION MADE: 11-OCT-12 BEIJING CH 102200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY AIRON CORPORATION 510(k) NO: K121379(TRADITIONAL) ATTN: G. ERIC GJERDE PHONE NO : 321 821 9433 751 North Dr Ste 6 SE DECISION MADE: 11-OCT-12 Melbourne FL 32934 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W CAYENNE MEDICAL, INC. 510(k) NO: K122463(SPECIAL) ATTN: KERESHMEH SHAHRIARI PHONE NO : 480 502 3661 16597 N. 92ND STREET SUITE 101 SE DECISION MADE: 11-OCT-12 SCOTTSDALE AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR Z REVISION HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K122778(SPECIAL) ATTN: DEAN NACHTRAB PHONE NO : 901 290 5812 5677 AIRLINE RD. SE DECISION MADE: 11-OCT-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) TEKMEDIC (M) SDN BHD 510(k) NO: K121591(TRADITIONAL) ATTN: PATRICK LEONG PHONE NO : 606 351095 9 PLOT 4, TANJUNG KLING INDUSTRIAL ASE DECISION MADE: 11-OCT-12 JETTY, TANJUNG KLING, MALACCA M510(k) STATEMENT DEVICE: FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 OSTIAL CORPORATION 510(k) NO: K122178(TRADITIONAL) ATTN: KAITLIN VON HOFFMANN PHONE NO : 650 903 9100 510 CLYDE AVENUE SE DECISION MADE: 11-OCT-12 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHON ANTERIOR CERVICAL PLATE SYSTE, NUVASIVE, INCORPORATED 510(k) NO: K122910(SPECIAL) ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549 7475 LUSK BOULEVARD SE DECISION MADE: 11-OCT-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CXI SUPPORT CATHETER COOK, INC. 510(k) NO: K122796(SPECIAL) ATTN: MOLLY BUSENBARK PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 11-OCT-12 Blmgtn IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEPAK 1000 DEFIBRILLATOR PHYSIO-CONTROL, INC. 510(k) NO: K122600(TRADITIONAL) ATTN: MICHELLE ACKERMANN PHONE NO : 425 867 4744 11811 WILLOWS RD., N.E. PO BOX 970SE DECISION MADE: 11-OCT-12 REDMOND WA 98073 9706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSURE(R) PS SYSTEM SPINE WAVE, INC. 510(k) NO: K122233(SPECIAL) ATTN: JOSEPH MERCADO PHONE NO : 203 944 9494 THREE ENTERPRISE DR. SUITE 210 SE DECISION MADE: 11-OCT-12 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL EXACTECH, INC. 510(k) NO: K122798(SPECIAL) ATTN: AMY TAULBEE PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 11-OCT-12 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUALIF CHALLENGING ACCESS PLATE SPINE SMITH PARTNERS L.P. 510(k) NO: K122168(SPECIAL) ATTN: CLIFTON NAIVAR PHONE NO : 512 637 2068 93 Red River SE DECISION MADE: 11-OCT-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K121883(TRADITIONAL) ATTN: SHANNON SCOTT PHONE NO : 210 515 4368 6203 FARINON DRIVE SE DECISION MADE: 11-OCT-12 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESA620 ELECTRICAL SAFETY ANALYZER FLUKE BIOMEDICAL 510(k) NO: K121722(TRADITIONAL) ATTN: JOHN NELSON PHONE NO : 440 498 2579 6045 COCHRAN RD. SE DECISION MADE: 11-OCT-12 SOLON OH 44139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY BECKMAN COULTER, INC 510(k) NO: K120199(TRADITIONAL) ATTN: BEVERLY HARDING PHONE NO : 972 831 3656 250 S. KRAEMER BLVD MAIL STOP A2 SSE DECISION MADE: 12-OCT-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TREGOR DUAL MOBILITY ACETABULAR SYSTEM ASTON MEDICAL 510(k) NO: K111981(TRADITIONAL) ATTN: CATHERINE GLOSTER PHONE NO : 805 679 1258 577 NORTH HOPE AVE SE DECISION MADE: 12-OCT-12 SANTA BARBARA CA 93110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM PRISMATIK DENTALCRAFT, INC. 510(k) NO: K121688(TRADITIONAL) ATTN: KATHLEEN DRAGOVICH PHONE NO : 949 399 1940 2212 DUPONT DR., ST P SE DECISION MADE: 12-OCT-12 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPICIDE OPA-28 TEST STRIP SERIM RESEARCH CORP. 510(k) NO: K120652(TRADITIONAL) ATTN: PATRICIA RUPCHOCK PHONE NO : 574 264 3440 3506 Reedy Dr SE DECISION MADE: 12-OCT-12 ELKHART IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETEST CEFTAROLINE BIOMERIEUX, INC. 510(k) NO: K121002(TRADITIONAL) ATTN: JENNIFER CHIA-HSUAN LIN PHONE NO : 314 731 8639 595 ANGLUM RD. SE DECISION MADE: 12-OCT-12 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ME HAIR2GO SYNERON MEDICAL LTD. 510(k) NO: K121598(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST, 29TH FLOOR SE DECISION MADE: 12-OCT-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESPIRE 7900, AESPIRE VIEW DATEX-OHMEDA 510(k) NO: K122445(SPECIAL) ATTN: JAMES RASKOB PHONE NO : 608 221 1551 PO BOX 7550 3030 OHMEDA DR SE DECISION MADE: 12-OCT-12 MADISON WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNISYN PLUS HIP STEM CONSENSUS ORTHOPEDICS, INC. 510(k) NO: K120595(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 916 355 7100 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 12-OCT-12 EL DORADO HILLS CA 95762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K122398(TRADITIONAL) ATTN: NOOR MALKI PHONE NO : 781 269 3401 2 EDGEWATER DRIVE SE DECISION MADE: 12-OCT-12 NORWOOD MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANCHORSURE NEOMEDIC INTERNATIONAL S.L. 510(k) NO: K120831(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 952 835 4018 7307 GLOUCHESTER DRIVE SE DECISION MADE: 12-OCT-12 EDINA MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE MEDTRONIC INC. 510(k) NO: K122811(SPECIAL) ATTN: JACQUELINE A HAUGE PHONE NO : 763 514 9967 7611 NORTHLAND DRIVE SE DECISION MADE: 12-OCT-12 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K121651(TRADITIONAL) ATTN: LESLIE FITCH PHONE NO : 901 867 4120 5677 AIRLINE RD. SE DECISION MADE: 12-OCT-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET MICROFIXATION NEURO PLATING SYSTEM BIOMET MICROFIXATION 510(k) NO: K121624(TRADITIONAL) ATTN: SHERYL MALMBERG PHONE NO : 904 741 9465 1520 TRADEPORT DR. SE DECISION MADE: 12-OCT-12 JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COCHLEAR BAHA IMPLANT SYSTEM COCHLEAR AMERICAS 510(k) NO: K121317(TRADITIONAL) ATTN: SEAN BUNDY PHONE NO : 800 523 5798 13059 E PEAKVIEW AVE SE DECISION MADE: 12-OCT-12 CENTENNIAL CO 80111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 EDAN INSTRUMENTS, INC. 510(k) NO: K122574(TRADITIONAL) ATTN: RANDY JIANG PHONE NO : 867 552 6856469 EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 12-OCT-12 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PIONEER STERNAL CABLE PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K122293(TRADITIONAL) ATTN: SARAH MCINTYRE PHONE NO : 906 225 5861 375 RIVER PARK CIRCLE SE DECISION MADE: 12-OCT-12 Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IFUSE IMPLANT SYSTEM SI-BONE, INC. 510(k) NO: K122074(TRADITIONAL) ATTN: CINDY DOMECUS PHONE NO : 650 343 4813 3055 OLIN AVE. SUITE 2200 SE DECISION MADE: 12-OCT-12 SAN JOSE CA 95128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS ADVANCED STERILIZATION PRODUCTS 510(k) NO: K112087(TRADITIONAL) ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DR. SE DECISION MADE: 15-OCT-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINGERTIP PULSE OXIMETER ANDON HEALTH CO., LTD 510(k) NO: K121697(TRADITIONAL) ATTN: LIU YI PHONE NO : 86 22 60526161 No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 15-OCT-12 TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOJECT 2 FOR GLASSY SYRINGE OWEN MUMFORD, LTD. 510(k) NO: K122837(SPECIAL) ATTN: DARREN MANSELL PHONE NO : 044 19 93812021 BROOK HILL SE DECISION MADE: 15-OCT-12 WOODSTOCK, OXFORDSHIRE UK 0X20I510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K121627(ABBREVIATED) ATTN: NATALIE P WILLIAMS PHONE NO : 901 399 5161 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 15-OCT-12 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTECH DENT AKERVALL TECHNOLOGIES INC 510(k) NO: K121272(TRADITIONAL) ATTN: SASSA AKERVALL PHONE NO : 800 444 0570 5520 STONE VALLEY DRIVE SE DECISION MADE: 15-OCT-12 ANN ARBOR MI 48105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRAM POSTITVE CLINDAMYCIN BIOMERIEUX, INC. 510(k) NO: K122547(TRADITIONAL) ATTN: ELIZABETH LANDON PHONE NO : 919 620 2329 595 ANGLUM RD. SE DECISION MADE: 15-OCT-12 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE CUTANEOUS ELECTRODE AMPCARE, LLC 510(k) NO: K121483(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 15-OCT-12 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM MEDICAL DESIGN LLC. 510(k) NO: K122497(TRADITIONAL) ATTN: KRISTI VONDRA PHONE NO : 605 275 1032 6709 S. MINNESOTA AVE. STE 204 SE DECISION MADE: 15-OCT-12 SIOUX FALLS SD 57108 2593 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) ABBOTT MEDICAL OPTICS INC 510(k) NO: K121721(TRADITIONAL) ATTN: ABBAS M BOHRA PHONE NO : 714 247 8488 1700 E. ST. ANDREW PLACE SE DECISION MADE: 15-OCT-12 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW RECHERCHES TECHNIQUES DENTAIRES (R510(k) NO: K122348(TRADITIONAL) ATTN: MANH-QUYNH CHU PHONE NO : 330 476 565666 3 RUE LOUIS NEEL SE DECISION MADE: 15-OCT-12 ST. EGREVE FR 38120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAVITY VARNISH DENTSPLY INTERNATIONAL, INC. 510(k) NO: K122331(TRADITIONAL) ATTN: HELEN LEWIS PHONE NO : 717 849 4229 221 W. PHILADELPHIA ST., SE 60 SE DECISION MADE: 15-OCT-12 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESKUSLIDES ANA HEP-2 AESKU.DIAGNOSTICS 510(k) NO: K120889(TRADITIONAL) ATTN: HELENE PAXTON PHONE NO : 443 253 4135 87 PEDRICKTOWN-WOODSTOWN RD SE DECISION MADE: 15-OCT-12 PEDRICKTOWN NJ 08067 510(k) STATEMENT DEVICE: DISPOSABLE SURGICAL GOWNS WEIHAI HONGYU NONWOVEN FABRIC PROD510(k) NO: K120192(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 16-OCT-12 WEIHAI CN 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER POLICHEM S.A. 510(k) NO: K112217(TRADITIONAL) ATTN: JOHN NYGAARD PHONE NO : 262 677 4121 1 PHARMACAL WAY SE DECISION MADE: 16-OCT-12 JACKSON WI 53037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS LARGE PORE POLYPROPHLENE MESH AMERICAN MEDICAL SYSTEMS 510(k) NO: K121805(TRADITIONAL) ATTN: RENEE MELLUM PHONE NO : 952 939 6458 10700 BREN ROAD WEST SE DECISION MADE: 16-OCT-12 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW R3 CONSTRAINED LINERS SMITH & NEPHEW, INC. 510(k) NO: K122139(TRADITIONAL) ATTN: MARTIN OSTMANN PHONE NO : 901 399 1809 1450 BROOKS RD. SE DECISION MADE: 16-OCT-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK INDUSTRIAL CLOTHINGS, LTD. 510(k) NO: K122465(TRADITIONAL) ATTN: S.N. HARI PHONE NO : 943 654 22200 D 17, SEETHAWAKA EXPORT PROCESSINGSE DECISION MADE: 16-OCT-12 AUISSAWELLA CE 10700 510(k) STATEMENT DEVICE: ACCUMESH DEPLOYMENT SYSTEM COVIDIEN LLC 510(k) NO: K123066(SPECIAL) ATTN: ELIZABETH MCMENIMAN PHONE NO : 781 839 1785 15 CROSBY DRIVE SE DECISION MADE: 16-OCT-12 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR XINWEI (SHANDONG) PLASTIC AND RUBB510(k) NO: K121992(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 16-OCT-12 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K121564(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 484 896 5688 3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 16-OCT-12 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOWERLOX PEDICLE SCREW SYSTEM CAPTIVA SPINE 510(k) NO: K122332(SPECIAL) ATTN: RICH JANSEN PHONE NO : 612 281 5505 13540 GUILD AVE SE DECISION MADE: 16-OCT-12 APPLE VALLY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO SAFE TOUCH HUBER INFUSION SET NIPRO MEDICAL CORPORATION 510(k) NO: K113470(TRADITIONAL) ATTN: JESSICA OSWALD PHONE NO : 305 599 7174 3150 N.W. 107TH AVE. SE DECISION MADE: 17-OCT-12 MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STINGRAY CERVICAL CAGE OMNI SURGICAL, LP DBA SPINE360 510(k) NO: K122085(ABBREVIATED) ATTN: DAVE LAMB PHONE NO : 512 327 6400 5000 Plaza on the Lake, Suite 305 SE DECISION MADE: 17-OCT-12 Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) MATANG MFG. SDN. BHD. 510(k) NO: K122131(TRADITIONAL) ATTN: LESLIE LEONG PHONE NO : 606 263 3129 LOT 10, KAWASAN PERINDUSTRIAN SERKSE DECISION MADE: 17-OCT-12 MERLIMAU, MELAKA MY 77300 510(k) STATEMENT DEVICE: GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE GLOBAL MEDI PRODUCTS 510(k) NO: K120641(TRADITIONAL) ATTN: ROBERT O DEAN PHONE NO : 716 440 7362 1083 DELWARE AVE. SE DECISION MADE: 17-OCT-12 BUFFALO NY 14209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THS INSTRUMENT TRAY HOLOGIC, INC. 510(k) NO: K120947(TRADITIONAL) ATTN: SARAH FAIRFIELD PHONE NO : 508 263 8857 250 CAMPUS DRIVE SE DECISION MADE: 17-OCT-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARTER GUIDEWIRE BRIVANT, LTD. 510(k) NO: K122856(SPECIAL) ATTN: KENNETH WALSH PHONE NO : 353 913 85037 PARKMORE WEST BUSINESS PARK SE DECISION MADE: 17-OCT-12 GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK BIO-RAD LABORATORIES 510(k) NO: K122838(TRADITIONAL) ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467 9500 JERONIMO RD. SE DECISION MADE: 17-OCT-12 IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR SORIN GROUP ITALIA S.R.L. 510(k) NO: K122844(SPECIAL) ATTN: SCOTT LIGHT PHONE NO : 303 467 6313 14401 W. 65TH WAY SE DECISION MADE: 17-OCT-12 ARVADA CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NU SLEEP RH ASSOCIATES LLC 510(k) NO: K121344(ABBREVIATED) ATTN: DANIELA LEVY PHONE NO : 213 447 5297 22817 VENTURA BLVD #161 SE DECISION MADE: 17-OCT-12 WOODLAND HILLS CA 91364 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOX PEEK VBR SYSTEM, INNOVASIS, INC. 510(k) NO: K121581(TRADITIONAL) ATTN: MARSHALL C MCCARTY PHONE NO : 801 261 2236 614 EAST 3900 SOUTH SE DECISION MADE: 17-OCT-12 SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QBTES QBTECH AB 510(k) NO: K122149(TRADITIONAL) ATTN: HANS BOSTROM PHONE NO : 46 70 6339209 Kungsgatan 29 SE DECISION MADE: 17-OCT-12 Stockholm SE 11156 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOWRIST STAPLER SYSTEM INTUITIVE SURGICAL, INC. 510(k) NO: K113706(TRADITIONAL) ATTN: MEGHNA SRIDHARAN PHONE NO : 408 523 2487 1266 Kifer Rd SE DECISION MADE: 17-OCT-12 Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPS E.MAX PRESS - ABUTMENT SOLUTIONS IVOCLAR VIVADENT AG 510(k) NO: K120053(TRADITIONAL) ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 2260 175 PINEVIEW DR. SE DECISION MADE: 18-OCT-12 AMHERST NY 14228 510(k) STATEMENT DEVICE: STERILE BLUNT FOR SINGLE USE SHANGHAI DOUBLE DOVE INDUSTRIAL CO510(k) NO: K120420(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 18-OCT-12 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE NIPRO MEDICAL CORPORATION 510(k) NO: K113469(TRADITIONAL) ATTN: JESSICA OSWALD PHONE NO : 305 599 7174 3150 N.W. 107TH AVE. SE DECISION MADE: 18-OCT-12 MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET NIPRO MEDICAL CORPORATION 510(k) NO: K113471(TRADITIONAL) ATTN: JESSICA OSWALD PHONE NO : 305 599 7174 3150 N.W. 107TH AVE. SE DECISION MADE: 18-OCT-12 MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COUGAR LS 15 LATERAL CAGE SYSTEM MEDOS INTERNATIONAL SARL 510(k) NO: K122896(SPECIAL) ATTN: KIRSTEN LEHMULLER PHONE NO : 508 828 3291 325 PARAMOUNT DRIVE SE DECISION MADE: 18-OCT-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N SMITH & NEPHEW, INC. 510(k) NO: K121861(TRADITIONAL) ATTN: KARIN DESJARDINS PHONE NO : 508 337 4035 150 MINUTEMAN RD. SE DECISION MADE: 18-OCT-12 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NMI HPICC III NAVILYST MEDICAL, INC. 510(k) NO: K122882(SPECIAL) ATTN: WANDA CARPINELLA PHONE NO : 508 658 7945 26 FOREST STREET SE DECISION MADE: 18-OCT-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) 4-WEB, INC. 510(k) NO: K121741(TRADITIONAL) ATTN: RICH JANSEN, PHARM, D. PHONE NO : 612 281 5505 13540 GUILD AVE. SE DECISION MADE: 18-OCT-12 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOMAIN SURGICAL SYSTEM DOMAIN SURGICAL, INC. 510(k) NO: K121881(TRADITIONAL) ATTN: CURTIS JENSEN PHONE NO : 801 924 4958 1370 SOUTH 2100 EAST SE DECISION MADE: 18-OCT-12 SALT LAKE SITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE CAREFUSION 510(k) NO: K121849(TRADITIONAL) ATTN: JOY GREIDANUS PHONE NO : 847 473 7404 1500 WAUKEGAN ROAD SE DECISION MADE: 18-OCT-12 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRCAST VENAFLOW ELITE SYSTEM DJO, LLC 510(k) NO: K122499(TRADITIONAL) ATTN: KEN FISHER PHONE NO : 760 734 5599 1430 DECISION STREET SE DECISION MADE: 18-OCT-12 VISTA CA 92081 8553 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX XN-SERIES SYSMEX AMERICA, INC. 510(k) NO: K112605(TRADITIONAL) ATTN: SHARITA BROOKS PHONE NO : 847 996 1648 577 Aptakisic Rd SE DECISION MADE: 19-OCT-12 Lincolnshire IL 60069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. 510(k) NO: K113219(TRADITIONAL) ATTN: JOHN MCLNTYRE PHONE NO : 949 837 3600 13900 Alton Pkwy Ste 123 SE DECISION MADE: 19-OCT-12 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS FACET SCREW SYSTEM APOLLO SPINE, INC. 510(k) NO: K120340(TRADITIONAL) ATTN: CHRISTINE SANTAGATE PHONE NO : 781 828 4400 75 MILL STREET SE DECISION MADE: 19-OCT-12 STOUGHTON MA 02072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XN CHECK STRECK 510(k) NO: K120742(TRADITIONAL) ATTN: DEBORAH S KIPP PHONE NO : 402 537 5215 7002 SOUTH 109TH ST. SE DECISION MADE: 19-OCT-12 OMAHA NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XN CHECK BF STRECK 510(k) NO: K120744(TRADITIONAL) ATTN: DEBORAH S KIPP PHONE NO : 402 537 5215 7002 SOUTH 109TH ST. SE DECISION MADE: 19-OCT-12 OMAHA NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XN CAL STRECK 510(k) NO: K120745(TRADITIONAL) ATTN: DEBORAH S KIPP PHONE NO : 402 537 5215 7002 SOUTH 109TH ST. SE DECISION MADE: 19-OCT-12 OMAHA NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC RAYENCE CO., LTD 510(k) NO: K122173(SPECIAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 19-OCT-12 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM MEDRAD, INC. 510(k) NO: K122916(SPECIAL) ATTN: BRIT BAIRD PHONE NO : 425 636 4137 10801 120TH AVENUE NE SE DECISION MADE: 19-OCT-12 KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 MEDTRONIC INC. 510(k) NO: K122913(TRADITIONAL) ATTN: MARY E DONLIN PHONE NO : 763 526 9172 7611 NORTHLAND DRIVE SE DECISION MADE: 19-OCT-12 BROOKLYN PARK MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAFITCUP CC TRIO EXTENSION MEDACTA INTERNATIONAL 510(k) NO: K122911(SPECIAL) ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 19-OCT-12 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LACRICATH LACRIMAL DUCT CATHETER QUEST MEDICAL, INC. 510(k) NO: K113867(TRADITIONAL) ATTN: AMY CLENDENING-WHEELER PHONE NO : 972 332 6338 ONE ALLENTOWN PKWY. SE DECISION MADE: 19-OCT-12 ALLEN TX 75002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER 3M COMPANY 510(k) NO: K121484(TRADITIONAL) ATTN: SUZANNE LEUNG PHONE NO : 651 575 8052 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 19-OCT-12 ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NONDISPOSABLE STIMULATING INSTRUMENTS NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K121931(TRADITIONAL) ATTN: CHRISTINE VERGELY PHONE NO : 805 866 6999 2225 SPERRY AVE, SUITE 1000 SE DECISION MADE: 19-OCT-12 VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SDX SYSTEM DYN'R SAS 510(k) NO: K121845(TRADITIONAL) ATTN: TIM LAWTON PHONE NO : 334 422 10734 74 COURS GAMBETTA SE DECISION MADE: 19-OCT-12 AIX EN PROVENCE FR 13100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B MEGO AFEK AC LTD 510(k) NO: K121962(TRADITIONAL) ATTN: ALEX RAPEL PHONE NO : 972 779 084276 KIBBUTZ AFEK SE DECISION MADE: 19-OCT-12 AFEK IS 30042 510(k) STATEMENT DEVICE: SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION SMITH & NEPHEW, INC. 510(k) NO: K122170(TRADITIONAL) ATTN: BRADLEY HEIL PHONE NO : 901 399 6339 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 19-OCT-12 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIRPRIME KURARAY NORITAKE DENTAL INC. 510(k) NO: K121980(TRADITIONAL) ATTN: IVAN WASSERMAN PHONE NO : 202 585 6529 700 12TH ST SW SUITE 100 SE DECISION MADE: 19-OCT-12 WASHINGTON DC 20005 510(k) STATEMENT DEVICE: ZFX DENTAL CAD SYSTEM ZIMMER DENTAL INC. 510(k) NO: K121709(TRADITIONAL) ATTN: CECILIA SILVA PHONE NO : 760 929 4300 1900 ASTON AVE. SE DECISION MADE: 19-OCT-12 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTECEM II CEMENT KIT AAP BIOMATERIALS GMBH 510(k) NO: K121876(ABBREVIATED) ATTN: VOLKER STIRNAL PHONE NO : 496 071 929220 LAGERSTRASSE 11-15 SE DECISION MADE: 19-OCT-12 DIEBURG GM D-64807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSTEK WRIST BLOOD PRESSURE MONITOR ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K122482(ABBREVIATED) ATTN: LEO WANG PHONE NO : 086 288 6083300 NO. 1 FANGHUA STREET HI-TECH ZONE SE DECISION MADE: 22-OCT-12 CHENGDU CH 610041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XN CAL PF STRECK 510(k) NO: K120747(TRADITIONAL) ATTN: DEBORAH S KIPP PHONE NO : 402 537 5215 7002 SOUTH 109TH ST. SE DECISION MADE: 22-OCT-12 OMAHA NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPRMETER CPR FEEDBACK DEVICE LAERDAL MEDICAL A/S 510(k) NO: K122050(TRADITIONAL) ATTN: DAN DILLION PHONE NO : 765 763 7537 1 GEDDES WAY SE DECISION MADE: 22-OCT-12 WEST LAFAYETTE IN 47906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS GOLD PTA DILATATION CATHETER C.R. BARD, INC. 510(k) NO: K122984(TRADITIONAL) ATTN: JENNIFER LOGVIN PHONE NO : 480 303 2752 1625 WEST 3RD ST. SE DECISION MADE: 22-OCT-12 TEMPE AZ 85281 1740 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM BIOMET MANUFACTURING CORP. 510(k) NO: K122277(TRADITIONAL) ATTN: ELIZABETH WRAY PHONE NO : 800 348 9500 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 22-OCT-12 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNASTY BIOFOAM SHELL WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K122382(SPECIAL) ATTN: DEAN NACHTRAB PHONE NO : 901 290 5812 5677 AIRLINE RD. SE DECISION MADE: 22-OCT-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHASIX PLUG AND PATCH C.R. BARD INC 510(k) NO: K120728(TRADITIONAL) ATTN: SHERMA WINSTON PHONE NO : 401 825 8737 100 CROSSINGS BOULEVARD SE DECISION MADE: 22-OCT-12 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K122898(TRADITIONAL) ATTN: KIRSTEN STOWELL PHONE NO : 610 404 3367 100 DENNIS DR. SE DECISION MADE: 22-OCT-12 Reading PA 19606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS ZIMMER, INC. 510(k) NO: K123019(SPECIAL) ATTN: REBECCA BROOKS PHONE NO : 574 371 8033 1800 WEST CENTER STREET SE DECISION MADE: 22-OCT-12 WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM MEDRANGE CORPORATION 510(k) NO: K122092(TRADITIONAL) ATTN: KUOFANG HUANG PHONE NO : 714 784 5202 480 Apollo St Ste D SE DECISION MADE: 23-OCT-12 Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESOLUTE FACET SCREW SYSTEM NEUROSTRUCTURES, LLC 510(k) NO: K121551(TRADITIONAL) ATTN: MEREDITH MAY PHONE NO : 719 337 7579 4628 NORTHPARK DR SE DECISION MADE: 23-OCT-12 COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HX-461 SEERS TECHNOLOGY CO, LTD 510(k) NO: K120545(TRADITIONAL) ATTN: PETER CHUNG PHONE NO : 412 687 3976 300 ATWOOD SE DECISION MADE: 23-OCT-12 PITTSBURGH PA 15213 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURICAL HIT GN OTOMETRICS 510(k) NO: K122028(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 23-OCT-12 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM CYDEN LIMITED 510(k) NO: K122280(TRADITIONAL) ATTN: AUSTIN SPEIER PHONE NO : 202 822 1850 2001 PENNSYLANIA AVE SUITE 950 SE DECISION MADE: 23-OCT-12 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR PROTON SYSTEMS 510(k) NO: K121657(TRADITIONAL) ATTN: MIKE BEGALA PHONE NO : 512 327 9997 611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 23-OCT-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORTEX PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC 510(k) NO: K120832(SPECIAL) ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8400 452 Alexandersville Rd SE DECISION MADE: 23-OCT-12 Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE SAGE LATERAL PLATE SYSTEM NUVASIVE, INC. 510(k) NO: K121815(TRADITIONAL) ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515 7475 LUSK BLVD SE DECISION MADE: 23-OCT-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEO RESMED LTD. 510(k) NO: K121705(SPECIAL) ATTN: JIM CASSI PHONE NO : 858 836 6081 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 23-OCT-12 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESTREAM VUE PACS CARESTREAM HEALTH, INC. 510(k) NO: K122523(TRADITIONAL) ATTN: ALEXANDRA CHAMBERLAIN PHONE NO : 585 627 8790 150 VERONA STREET SE DECISION MADE: 23-OCT-12 ROCHESTER NY 14608 510(k) STATEMENT DEVICE: ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE COVIDIEN 510(k) NO: K123109(SPECIAL) ATTN: RENEE BORGESANO PHONE NO : 203 492 5325 60 MIDDLETOWN AVE. SE DECISION MADE: 23-OCT-12 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOFLEX SB INFLATABLE BONE TAMP OSSEON THERAPEUTICS, INC. 510(k) NO: K122533(TRADITIONAL) ATTN: KEITH BURGER PHONE NO : 707 636 5940 2330 Circadian Way SE DECISION MADE: 23-OCT-12 Santa Rosa CA 95407 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CDC ZIRCONIA BLANKS CONTINENTAL DENTAL CERAMICS, INC. 510(k) NO: K122972(TRADITIONAL) ATTN: JERRY DOVIACK, CDT PHONE NO : 310 618 8821 1873 WESTERN WAY SE DECISION MADE: 24-OCT-12 TORRANCE CA 90501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER CAREFUSION 510(k) NO: K122422(TRADITIONAL) ATTN: JOY GREIDANUS PHONE NO : 847 473 7404 1500 WAUKEGAN ROAD SE DECISION MADE: 24-OCT-12 MCGAW PARK \ IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET LATERAL SPACER SYSTEM BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K122989(TRADITIONAL) ATTN: MARGARET F CROWE PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 24-OCT-12 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOFFMANN 3 STRYKER CORP. 510(k) NO: K122284(TRADITIONAL) ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 24-OCT-12 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGE-COM 5.0 TOM TEC IMAGING SYSTEMS GMBH 510(k) NO: K122289(TRADITIONAL) ATTN: BERNHARD MUMM PHONE NO : 498 932 175605 EDISONSTR. 6 SE DECISION MADE: 24-OCT-12 UNTERSCHLEISSHEIM GM 85716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAMEDULLARY NAIL SYSTEM WEIGAO ORTHOPAEDIC DEVICE CO., LTD510(k) NO: K121312(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 PO BOX 237-023 SE DECISION MADE: 24-OCT-12 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHAPEMATCH CUTTING GUIDE STRYKER CORP. 510(k) NO: K122053(TRADITIONAL) ATTN: TAMMY WHARTON PHONE NO : 510 995 4462 1600 HARBOR BAY DRIVE SUITE 200 SE DECISION MADE: 24-OCT-12 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGEN3D CARDIOVASCULAR IMAGING TECHNOLOGIE510(k) NO: K122241(TRADITIONAL) ATTN: MELANIE HASEK PHONE NO : 913 410 2357 9755 RIDGE DRIVE SE DECISION MADE: 24-OCT-12 LENEXA KS 66219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRE FIXED WIRE BALLON DILATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K122924(SPECIAL) ATTN: JANIS F TARANTO PHONE NO : 508 683 4560 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 24-OCT-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS ECO2 SLIDES ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K120765(SPECIAL) ATTN: GAOZHEN HANG PHONE NO : 585 453 3962 100 INDIGO CREEK DR. SE DECISION MADE: 24-OCT-12 ROCHESTER NY 14626 5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT TGM MEDICAL, INC. 510(k) NO: K121636(TRADITIONAL) ATTN: PRAKASH PAI PHONE NO : 916 358 8835 5145 Golden Foothill Parkway SUITESE DECISION MADE: 24-OCT-12 El Dorado Hills CA 95762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K122292(TRADITIONAL) ATTN: BRET M BERRY PHONE NO : 801 295 3280 545 WEST 500 SOUTH SUITE 100 SE DECISION MADE: 24-OCT-12 BOUNTIFUL UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW SMF HIP STEM SMITH & NEPHEW, INC. 510(k) NO: K123012(SPECIAL) ATTN: NATALIE P WILLIAMS PHONE NO : 901 339 5161 1450 BROOKS RD. SE DECISION MADE: 24-OCT-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS IMMCO DIAGNOSTICS, INC. 510(k) NO: K113020(TRADITIONAL) ATTN: KEVIN J LAWSON PHONE NO : 716 691 0091 60 PINEVIEW DR. SE DECISION MADE: 25-OCT-12 BUFFALO NY 14228 2120 510(k) STATEMENT DEVICE: CLICKFINE PEN NEEDLE P/L BIOMEDICAL 510(k) NO: K122969(SPECIAL) ATTN: LEE LEICHTER PHONE NO : 239 244 1448 10882 STONIGTON AVE SE DECISION MADE: 25-OCT-12 FORT MYERS FL 33913 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLICKFINE PEN NEEDLE P/L BIOMEDICAL 510(k) NO: K122971(SPECIAL) ATTN: LEE LEICHTER PHONE NO : 239 244 1448 10882 STONIGTON AVE SE DECISION MADE: 25-OCT-12 FORT MYERS FL 33913 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANCHOR-L LUMBAR CAGE STRYKER SPINE 510(k) NO: K120869(TRADITIONAL) ATTN: TIFFANI ROGERS PHONE NO : 201 760 8206 2 PEARL COURT SE DECISION MADE: 25-OCT-12 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRMA C02 MODEL 200101; IRMA AX 200601 PHASEIN AB 510(k) NO: K123043(SPECIAL) ATTN: DAVID WEISSBURG PHONE NO : 608 770 0223 404 WILLIAMSON ST. SUITE 402 SE DECISION MADE: 25-OCT-12 MADISON WI 53703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE 8CH FOOT ANKLE COIL GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K122694(TRADITIONAL) ATTN: GLEN SABIN PHONE NO : 262 521 6848 3200 N GRANDVIEW BLVD MAIL CODE-W-SE DECISION MADE: 25-OCT-12 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEALTH 360 ORBITAL PAD SYSTEM CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K122987(SPECIAL) ATTN: MAUREEN MCDONNELL PHONE NO : 651 259 1644 651 CAMPUS DR. SE DECISION MADE: 25-OCT-12 ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI 3 OXYGEN SYSTEM CAIRE, INC. 510(k) NO: K120785(SPECIAL) ATTN: BRIAN JARRELL PHONE NO : 858 202 3157 12230 WORLD TRADE DRIVE, SUITE 100SE DECISION MADE: 25-OCT-12 SAN DIEGO CA 92128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) TEKMEDIC (M) SDN BHD 510(k) NO: K121594(TRADITIONAL) ATTN: PATRICK LEONG PHONE NO : 606 351095 9 PLOT 4, TANJUNG KLING INDUSTRIAL ASE DECISION MADE: 25-OCT-12 JETTY, TANJUNG KLING, MALACCA M510(k) STATEMENT DEVICE: FUSELOX LUMBAR INTERBODY FUSION DEVICE CAPTIVA SPINE 510(k) NO: K122956(SPECIAL) ATTN: RICH JANSEN PHONE NO : 612 281 5505 13540 GUILD AVE SE DECISION MADE: 25-OCT-12 APPLE VALLY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS INTUITIVE SURGICAL, INC. 510(k) NO: K121921(TRADITIONAL) ATTN: CHERECE L JONES PHONE NO : 408 523 6925 1266 KIFER ROAD SE DECISION MADE: 25-OCT-12 SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSEAL TRIO TISSUE SEALING DEVICE ETHICON ENDO-SURGERY, LLC 510(k) NO: K123141(SPECIAL) ATTN: EMILY KREUTZKAMP PHONE NO : 513 337 1546 4545 CREEK ROAD SE DECISION MADE: 25-OCT-12 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE SUNWELL BIOTECH CO., LTD 510(k) NO: K121637(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 25-OCT-12 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR TRANSENTERIX, INC. 510(k) NO: K122299(TRADITIONAL) ATTN: TAMMY B CARREA PHONE NO : 919 765 8420 635 DAVIS DRIVE SUITE 300 SE DECISION MADE: 25-OCT-12 DURHAM NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM HAEMONETICS CORP. 510(k) NO: K122262(TRADITIONAL) ATTN: ERICA DIAZ PHONE NO : 781 356 9798 400 Wood Rd SE DECISION MADE: 25-OCT-12 BRAINTREE MA 02184 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL ELECTROCARDIOGRAPH SHENZHEN BIOCARE ELECTRONICS CO., 510(k) NO: K122712(SPECIAL) ATTN: DIANA HONG PHONE NO : 86 212 2815850 P.O. BOX 237-023 SE DECISION MADE: 25-OCT-12 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT HEIDELBERG ENGINEERING GMBH 510(k) NO: K121993(TRADITIONAL) ATTN: DIANE HORWITZ, PH.D. PHONE NO : 703 307 2921 2995 STEVEN MARTIN DR. SE DECISION MADE: 25-OCT-12 FAIRFAX VA 22031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPERMFREEZE SOLUTION VITROLIFE SWEDEN AB 510(k) NO: K113786(TRADITIONAL) ATTN: NINA ARVIDSSON PHONE NO : 463 172 18076 BOX 9080 SE DECISION MADE: 26-OCT-12 GOTEBORG SW SE-40092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEGACY-500 MT TABLES, LLC 510(k) NO: K111588(TRADITIONAL) ATTN: MILBURN TENNIS PHONE NO : 417 678 2880 15 W. MILL STREET SE DECISION MADE: 26-OCT-12 AURORA MO 65605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM SWAN VALLEY MEDICAL, INCORPORATED 510(k) NO: K120127(TRADITIONAL) ATTN: KEVIN RANDALL PHONE NO : 303 828 0844 16576 W. 53RD WAY SE DECISION MADE: 26-OCT-12 GOLDEN CO 80403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL FULLY AUTOMATIC AED PLUS ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K120406(TRADITIONAL) ATTN: TANMAY B SHUKLA PHONE NO : 978 421 9171 269 MILL ROAD SE DECISION MADE: 26-OCT-12 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHONAVIGATOR RELEASE 1 PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K121781(ABBREVIATED) ATTN: FRANS JACOBS PHONE NO : 316 512 0741 VEENPLUIS 4-6 SE DECISION MADE: 26-OCT-12 BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER SUPERDIMENSION INC. 510(k) NO: K120796(TRADITIONAL) ATTN: KARYL HASKELL PHONE NO : 763 210 4000 161 CHESHIRE LANE NORTH SUITE 100 SE DECISION MADE: 26-OCT-12 Minneapolis MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING MEDTECH PRODUCTS LTD. 510(k) NO: K120930(TRADITIONAL) ATTN: CLAIRE RYAN PHONE NO : 440 127 0500019 ELECTRA HOUSE, CREWE BUSINESS PARKSE DECISION MADE: 26-OCT-12 CHESHIRE UK CW1 6GL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL90 FLEX RADIOMETER MEDICAL APS 510(k) NO: K122642(SPECIAL) ATTN: MARTIN GABLER PHONE NO : 45 38 273114 AKANDEVEJ 21 SE DECISION MADE: 26-OCT-12 BRONSHOJ DA DK-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS ST. SHINE OPTICAL CO., LTD. 510(k) NO: K121201(TRADITIONAL) ATTN: ELLA LEE PHONE NO : 886 226 479356 4,5 F/L NO. 276-2 SEC. 1 TATUNG RDSE DECISION MADE: 26-OCT-12 NEW TAIPEI CITY TW 221 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123001(TRADITIONAL) ATTN: SHELLY PEARCE PHONE NO : 650 694 5988 685 East Middlefield Road SE DECISION MADE: 26-OCT-12 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM BIO-RAD LABORATORIES, INC., CLINIC510(k) NO: K122472(TRADITIONAL) ATTN: JACKIE BUCKLEY PHONE NO : 510 741 5309 4000 Alfred Nobel Drive SE DECISION MADE: 26-OCT-12 Hercules CA 94547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE CANARY SYSTEM QUANTUM DENTAL TECHNOLOGIES INC 510(k) NO: K112139(TRADITIONAL) ATTN: JOSH SILVERTOWN PHONE NO : 647 205 4402 748 BRIAR HILL AVENUE SE DECISION MADE: 26-OCT-12 TORONTO, ONTARIO CA M6B 1L3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUIDBAND FLOW CONTROL ADVANCED MEDICAL SOLUTIONS (PLYMOU510(k) NO: K122446(TRADITIONAL) ATTN: MICHAEL BROWNE PHONE NO : 441 752 209955 WESTERN WOOD WAY LANAGAGE SCIENCE SE DECISION MADE: 26-OCT-12 PLYMOUTH UK PL7 5BG 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLUMBUS REVISION KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K122985(SPECIAL) ATTN: JULIE TOM WING PHONE NO : 610 984 9147 3773 CORPORATE PWKY. SE DECISION MADE: 26-OCT-12 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL, INC. 510(k) NO: K122215(SPECIAL) ATTN: TANYA EBERLE PHONE NO : 770 754 3800 6120 Windward Pkwy Ste 220 SE DECISION MADE: 26-OCT-12 Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOW2, SWING THYSSENKRUPP ACCESSIBILITY B.V. 510(k) NO: K121561(TRADITIONAL) ATTN: ARNOLD HEIDEN PHONE NO : 31 180 530900 VAN UTRECHTWEG 99 KRIMPEN AAN DEN SE DECISION MADE: 26-OCT-12 ZUID-HOLLAND NL 2921 LN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKINTEMP II HUMAN BIOSCIENCES, INC. 510(k) NO: K122325(TRADITIONAL) ATTN: JACK SLOVICK PHONE NO : 763 639 0238 2913, 209TH LANE NW SE DECISION MADE: 26-OCT-12 OAK GROVE MN 55011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENEW INSERT RENEW MEDICAL, INC. 510(k) NO: K122003(TRADITIONAL) ATTN: VICTORIA MACKINNON PHONE NO : 650 863 3167 532 EMERSON STREET SE DECISION MADE: 26-OCT-12 PALO ALTO CA 94301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORQUE DEVICE BOSTON SCIENTIFIC CORPORATION 510(k) NO: K123024(SPECIAL) ATTN: RACHEL OWENS PHONE NO : 763 494 1491 ONE SCIMED PLACE SE DECISION MADE: 26-OCT-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REX ANTERIOR CERVICAL PLATE SYSTEM DIO MEDICAL CO., LTD. 510(k) NO: K121862(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N. PUENTE ST UNIT B SE DECISION MADE: 30-OCT-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPRO HEMI-EDGE TOE SYSTEM BIOPRO, INC. 510(k) NO: K121973(TRADITIONAL) ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858 3150 E. 200TH ST SE DECISION MADE: 30-OCT-12 PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERGOSELECT/GE ERGOLINE GMBH 510(k) NO: K112121(TRADITIONAL) ATTN: ANDREA PECSI PHONE NO : 497 462 924051 SCHWARZWALDSTRASSE 5 SE DECISION MADE: 31-OCT-12 TUTTLINGEN GM 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM AAP IMPLANTATE AG 510(k) NO: K113602(TRADITIONAL) ATTN: MARC SEEGERS PHONE NO : 004 930 75019192 LORENZWEG 5 SE DECISION MADE: 31-OCT-12 BERLIN GM 12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOFRIC PRIMO, LOFRIC HYDRO-KIT ASTRA TECH, INC. 510(k) NO: K122078(TRADITIONAL) ATTN: ALLISON C KOMIYAMA PHONE NO : 858 792 1235 11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 31-OCT-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED TREVO RETRIEVER CONCENTRIC MEDICAL, INC. 510(k) NO: K122478(TRADITIONAL) ATTN: CHRISTINA ROWE PHONE NO : 510 413 2486 301 E Evelyn Ave SE DECISION MADE: 31-OCT-12 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSENSE CAPNIA, INC. 510(k) NO: K121768(TRADITIONAL) ATTN: JULIE BLACKLOCK PHONE NO : 650 213 8444 2445 FABER PLACE, STUITE 250 SE DECISION MADE: 31-OCT-12 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WINX SLEEP THERAPY SYSTEM APNICURE, INC. 510(k) NO: K122130(SPECIAL) ATTN: CHRIS DANIEL PHONE NO : 650 361 9300 900 CHESAPEAKE DR SE DECISION MADE: 31-OCT-12 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANOPY LAMINOPLASTY FIXATION SYSTEM GLOBUS MEDICAL INC. 510(k) NO: K121732(SPECIAL) ATTN: SARAH MARIE FITZGERALD PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 31-OCT-12 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL MEDTRONIC XOMED 510(k) NO: K122434(SPECIAL) ATTN: ANTOINE KOUCHAKJY PHONE NO : 904 296 9600 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 31-OCT-12 JACKSONVILLE FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM STRYKER 510(k) NO: K122313(TRADITIONAL) ATTN: ROB YAMASHITA PHONE NO : 269 389 4258 750 TRADE CENTER WAY STE 200 SE DECISION MADE: 31-OCT-12 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY CAYENNE MEDICAL, INC. 510(k) NO: K122314(TRADITIONAL) ATTN: KERESHMEH SHAHRIARI PHONE NO : 480 502 3661 16597 N. 92ND STREET SUITE 101 SE DECISION MADE: 31-OCT-12 SCOTTSDALE AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERTEX SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC 510(k) NO: K122163(TRADITIONAL) ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8400 452 Alexandersville Rd SE DECISION MADE: 31-OCT-12 Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIFLEX TINNITUS TECHNOLOGY STARKEY LABORATORIES 510(k) NO: K122876(TRADITIONAL) ATTN: KEN MEYER PHONE NO : 952 947 4734 6600-6700 WASHINGTON AVE SO. SE DECISION MADE: 31-OCT-12 EDEN PRAIRIE MN 55344 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW TOTAL 510(k)s THIS PERIOD 260 TOTAL WITH SUMMARIES 249 TOTAL WITH STATEMENTS 11
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