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U.S. FDA Medical Device Socket Pusher 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 Socket Pusher companies with:

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