21 C.F.R. § 888.3010
Bone fixation cerclage.
Cite as 21 C.F.R. § 888.3010 (2026)
(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.