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U.S. FDA Medical Device Bone Cutting Instrument Requirements: Bone Cutting Instrument

FDA Medical Device Definition: A bone cutting instrument is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw

Registrar Corp assists Bone Cutting Instrument companies with:

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




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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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