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

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