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