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e-CFR data is current as of July 14, 2020

Title 21Chapter ISubchapter HPart 888Subpart D → §888.3010


Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices


§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.

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