Orthopedic devices: classification and reclassification of pedicle screw spinal systems; technical amendment. Final rule; technical amendment.
The Food and Drug Administration (FDA) is correcting a final rule that classified certain previously unclassified pre amendments pedicle screw spinal systems and reclassified certain post amendments pedicle screw spinal systems. The agency is correcting the rule to include an intended use that was inadvertently omitted from the codified language in the rule. In addition, the agency is correcting the rule to clarify that, when intended for certain uses, the device is a pre amendments, not a post amendments, device. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).
D001863:Bone Screws / Q000145:classification*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D013168:Spondylolisthesis / Q000601:surgery; D014481:United States; D014486:United States Food and Drug Administration