21 C.F.R. § 888.3040

Smooth or threaded metallic bone fixation fastener.

Last amended: 2016Year: 2026Length: 113 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 888.3040 (2026)

(a) Identification. 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. (b) Classification. Class II.
21 C.F.R. § 888.3040: Smooth or threaded metallic bone fixation fastener. | Justis AI