21 CFR 888.3010
§ 888.3010 Bone fixation cerclage.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.3010, § 888.3010 Bone fixation cerclage, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91054
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.