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U.S. FDA Medical Device Bone Cap Requirements

FDA Medical Device Definition: A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.

Registrar Corp assists Bone Cap companies with:

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