---
kind: "section"
citation: "21 C.F.R. § 888.3015"
title: "21"
number: "888.3015"
heading: "Bone heterograft."
url: "https://uscodex.org/cfr/21/888.3015"
---

# §888.3015. Bone heterograft.

- (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](/cfr/21/515.md) of the act is required before this device may be commercially distributed. See [§ 888.3](/cfr/21/888.3.md).

## Notes

### 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.