21 C.F.R. § 888.3010

Current through October 31, 2024
Section 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.

21 C.F.R. §888.3010