View all text of Subpart D [§ 888.3000 - § 888.3810]
§ 888.3010 - Bone fixation cerclage.
(a) Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.
(b) Classification. Class II.