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U.S. FDA Medical Device Fork 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 Fork companies with:

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