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.
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.
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