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