U.S. FDA Medical Device Traction Apparatus Requirements
FDA Medical Device Definition: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
FDA Traction Apparatus Label Requirements and Exceptions
FDA Traction Apparatus Import Information
FDA Traction Apparatus Detentions (Traction Apparatus Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Traction Apparatus Manufacturers (Traction Apparatus Suppliers)
- Traction Apparatus Distributors
- Traction Apparatus Processors
- Traction Apparatus Repackers
- Traction Apparatus Relabelers
- Traction Apparatus Exporters
- Traction Apparatus Importers
For more information about Traction Apparatus 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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