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U.S. FDA Medical Device Cerclage Applier 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 Cerclage Applier companies with:

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