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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR888.3015]
 See Related Information on Bone heterograft. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 888 -- ORTHOPEDIC DEVICES

Subpart D - Prosthetic Devices

Sec. 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 of the act is required before this device may be commercially distributed. See § 888.3.

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