OVE · Intervertebral Fusion Device With Integrated Fixation, Cervical
Orthopedic · 21 CFR 888.3080 · Class 2
Overview
| Product Code | OVE |
|---|---|
| Device Name | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| 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.
Recent Cleared Devices (20 of 158)
Showing 20 most recent of 158 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252774 | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | Apr 15, 2026 | SESE |
| K260038 | E3D-C Interbody System | Evolution Spine | Feb 4, 2026 | SESE |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Globus Medical, Inc. | Dec 22, 2025 | SESE |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | Dec 11, 2025 | SESE |
| K250076 | Endeavor Stand-Alone Cervical IBF System | Innovasis | Sep 25, 2025 | SESE |
| K250540 | SABER-C System | Elevation Spine | Aug 8, 2025 | SESE |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | Jul 30, 2025 | SESE |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | Jun 27, 2025 | SESE |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | Apr 25, 2025 | SESE |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | Apr 10, 2025 | SESE |
| K243188 | CYLOX® ST | Signus Medizintechnik GmbH | Feb 11, 2025 | SESE |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine | Feb 7, 2025 | SESE |
| K242517 | ProAM ACDF System | Pro Surgical, Inc. | Nov 20, 2024 | SESE |
| K241846 | E3D-C Interbody System | Evolution Spine | Aug 12, 2024 | SESE |
| K241467 | Stable-C Interbody System | Nexus Spine, LLC | Jul 17, 2024 | SESE |
| K240699 | SCARLET® AC-Ti | Spineart SA | May 10, 2024 | SESE |
| K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | Apr 19, 2024 | SESE |
| K240715 | Idys® C ZP 3DTi | Clariance | Mar 22, 2024 | SESE |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | Dec 13, 2023 | SESE |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation | Nov 28, 2023 | SESE |
Top Applicants
- SeaSpine Orthopedics Corporation — 8 clearances
- Genesys Spine — 6 clearances
- Centinel Spine, Inc. — 4 clearances
- Globus Medical, Inc. — 4 clearances
- Life Spine, Inc. — 4 clearances
