eCFR Reference Browser

---

title: "21 CFR §888.3015"

source: "https://www.ecfr.gov/current/title-21/section-888.3015"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "888"

part_subject: "ORTHOPEDIC DEVICES"

subpart_code: "D"

subpart_subject: "Prosthetic Devices"

section_number: "888.3015"

section_subject: "Bone heterograft."

cfr_reference: "21 CFR 888.3015"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§888.3015 - Bone heterograft.