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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.

Registrar Corp assists Clavicle Splint companies with:

  • FDA Clavicle Splint Establishment Registration
  • FDA Clavicle Splint Listing
  • 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.

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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