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