Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart D - Prosthetic Devices / § 888.3010 Bone fixation cerclage.
§ 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.