U.S. FDA Medical Device Prosthesis Driver Requirements
FDA Medical Device Definition: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
FDA Prosthesis Driver Label Requirements and Exceptions
FDA Prosthesis Driver Import Information
FDA Prosthesis Driver Detentions (Prosthesis Driver Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Prosthesis Driver Manufacturers (Prosthesis Driver Suppliers)
- Prosthesis Driver Distributors
- Prosthesis Driver Processors
- Prosthesis Driver Repackers
- Prosthesis Driver Relabelers
- Prosthesis Driver Exporters
- Prosthesis Driver Importers
For more information about Prosthesis Driver Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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