Food and Drug Administration

Orthopeadic & Rehabilitation Devices Panel

June 3, 2004

Hip Guidance Review (HTM) (PPT)

Knee Reclassification Cover Letter Memorandum (HTM) (PDF) (Word)

Knee Reclassification Lead Reveiwer Memorandum (HTM) (PDF) (Word)

Knee Reclassification Clinical Memorandum (HTM) (PDF) (Word)

Knee Reclassification Deficiency Letter (HTM) (PDF) (Word)

Device Classification and Reclassification, Marjorie Shulman (HTM) (PPT)