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U.S. FDA Medical Device Post Surgical Pylon Requirements

FDA Medical Device Definition: A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

Registrar Corp assists Post Surgical Pylon companies with:

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