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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.

Registrar Corp assists Femoral Neck Punch companies with:

  • FDA Femoral Neck Punch Establishment Registration
  • FDA Femoral Neck Punch Listing
  • 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.


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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