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§888.3010. Bone fixation cerclage.

21 C.F.R. § 888.3010

(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.
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.