§ 888.3040. Smooth or threaded metallic bone fixation fastener.
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/us/cfr/t21/s§ 888.3040·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.