U.S. FDA Medical Device Staple 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 Staple Driver Label Requirements and Exceptions
FDA Staple Driver Import Information
FDA Staple Driver Detentions (Staple Driver Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Staple Driver Manufacturers (Staple Driver Suppliers)
- Staple Driver Distributors
- Staple Driver Processors
- Staple Driver Repackers
- Staple Driver Relabelers
- Staple Driver Exporters
- Staple Driver Importers
For more information about Staple 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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