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U.S. FDA Medical Device Orthopedic Burr 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 Burr companies with:

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