Code of Federal Regulations · Section

§ 888.3010 — Bone Fixation Cerclage

21 C.F.R. § 888.3010

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(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.

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