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 Pin Crimper Detentions (Pin Crimper Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Pin Crimper Manufacturers (Pin Crimper Suppliers)
- Pin Crimper Distributors
- Pin Crimper Processors
- Pin Crimper Repackers
- Pin Crimper Relabelers
- Pin Crimper Exporters
- Pin Crimper Importers
For more information about Pin Crimper 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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