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U.S. FDA Medical Device Cervical 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 Cervical Orthosis companies with:

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