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U.S. FDA Medical Device Bone Skid 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 Skid companies with:

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