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U.S. FDA Medical Device Staple Driver 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 Staple Driver companies with:

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