Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Bone Mill Regulations

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

  • FDA Bone Mill Establishment Registration
  • FDA Bone Mill Listing
  • FDA Bone Mill Label Requirements and Exceptions
  • FDA Bone Mill Import Information
  • FDA Bone Mill Detentions (Bone Mill Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Bone Mill Manufacturers (Bone Mill Suppliers)
       - Bone Mill Distributors
       - Bone Mill Processors
       - Bone Mill Repackers
       - Bone Mill Relabelers
       - Bone Mill Exporters
       - Bone Mill Importers
For more information about Bone Mill 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco