PHM · Intervertebral Fusion Device With Bone Graft, Thoracic
Orthopedic · 21 CFR 888.3080 · Class 2
Overview
| Product Code | PHM |
|---|---|
| Device Name | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Classification Rationale
(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.
Special Controls
*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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | May 31, 2018 | SESE |
| K160958 | Battalion Universal Spacer System | Alphatec Spine | Sep 8, 2016 | SESE |
| K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | Jun 17, 2015 | SESE |
Top Applicants
- Nu Vasive, Incorporated — 1 clearance
- Alphatec Spine, Inc. — 1 clearance
- Alphatec Spine — 1 clearance
