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U.S. FDA Medical Device Pin Crimper 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 Pin Crimper companies with:

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