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.
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.
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