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U.S. FDA Medical Device Surgical Orthopedic Scissors 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 Surgical Orthopedic Scissors companies with:

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