21 CFR § 888.3010 Orthopedic Devices

§ 888.3010 Bone fixation cerclage.

Current through Sep 8, 2026 · Read all of Part 888

(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.

← § 888.3000 Bone cap.§ 888.3015 Bone heterograft. →