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U.S. FDA Medical Device Prosthesis Alignment Device 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 Prosthesis Alignment Device companies with:

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