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U.S. FDA Medical Device Soft Rib Fracture Orthosis Requirements


FDA Medical Device Definition: A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

Registrar Corp assists Soft Rib Fracture Orthosis companies with:

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