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U.S. FDA Medical Device 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 Passer companies with:

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