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