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U.S. FDA Medical Device Orthopedic Needle Holder 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 Needle Holder companies with:

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