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U.S. FDA Medical Device Impactor 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.

Registrar Corp assists Impactor companies with:

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






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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