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U.S. FDA Medical Device Finger Joint Polymer Constrained Prosthesis Requirements: Finger Joint Polymer Constrained Prosthesis

FDA Medical Device Definition: A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve

Registrar Corp assists Finger Joint Polymer Constrained Prosthesis companies with:

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


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