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

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