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Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures (Final Rule) Final Regulatory Impact Analysis

The Food and Drug Administration (FDA) is issuing a final rule to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately requiring the filing of a premarket approval application. FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device.

Regulatory Impact Analysis

Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures (Final Rule) Final Regulatory Impact Analysis (PDF - 206.04 KB)

Federal Register: 88 FR 18987

Publication date: March 30th 2023

Docket No. FDA-2021-N-0310

 
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