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Title 21 Part 888 → Subpart D → §888.3080

Title 21 → Chapter I → Subchapter H → Part 888 → Subpart D → §888.3080

Electronic Code of Federal Regulations e-CFR

Title 21 Part 888 → Subpart D → §888.3080

e-CFR data is current as of January 27, 2020

Title 21Chapter ISubchapter HPart 888Subpart D → §888.3080


Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices


§888.3080   Intervertebral body fusion device.

(a) Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

(b) Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See §888.1(e) for the availability of this guidance document.

(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.

(c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[72 FR 32172, June 12, 2007]