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52 FR 33702, Sept. 4, 1987, unless otherwise noted.
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Nomenclature changes to part 888 appear at 73 FR 35341, June 23, 2008.
(a) Identification. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 888.3.