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.
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.
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