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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.

Registrar Corp assists Orthopedic Knife companies with:

  • FDA Orthopedic Knife Establishment Registration
  • FDA Orthopedic Knife Listing
  • 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.

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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