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U.S. FDA Medical Device Bone Screw Starter 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 Bone Screw Starter companies with:

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