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U.S. FDA Medical Device Orthopedic Wire Passer 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 Wire Passer companies with:

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