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U.S. FDA Medical Device Drill Brace 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 Drill Brace companies with:

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