Orthopedic devices; reclassification of the intervertebral body fusion device. Final rule.
The Food and Drug Administration (FDA) is reclassifying intervertebral body fusion devices that contain bone grafting material, from class III (premarket approval) into class II (special controls), and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. This reclassification is based upon on the recommendation of the Orthopaedic and Rehabilitation Devices Panel (the Panel).
D016025:Bone Transplantation / Q000145:classification / Q000295:instrumentation*; D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D009983:Orthopedic Equipment / Q000145:classification*; D013123:Spinal Fusion / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration