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U.S. FDA Medical Device Traction Splint Requirements

FDA Medical Device Definition: A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.

Registrar Corp assists Traction Splint companies with:

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