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U.S. FDA Medical Device Facial Fracture Appliance Requirements


FDA Medical Device Definition: An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.

Registrar Corp assists Facial Fracture Appliance companies with:

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