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U.S. FDA Medical Device Hollow Mill Set 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 Hollow Mill Set companies with:

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