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U.S. FDA Medical Device Lumbo-Sacral 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 Lumbo-Sacral Orthosis companies with:

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