ODP · Intervertebral Fusion Device With Bone Graft, Cervical
Orthopedic · 21 CFR 888.3080 · Class 2
Overview
| Product Code | ODP |
|---|---|
| Device Name | Intervertebral Fusion Device With Bone Graft, 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 349)
Showing 20 most recent of 349 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | May 16, 2026 | SESE |
| K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | May 12, 2026 | SESE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | Apr 24, 2026 | SESE |
| K253260 | ORIO-3D Cage System | SpineCraft | Apr 16, 2026 | SESE |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | Apr 13, 2026 | SESE |
| K242303 | MOD-C | Orthomod, LLC | Apr 1, 2026 | SESE |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | Mar 30, 2026 | SESE |
| K252432 | Flex-Z™ Cervical Cage | Spinepoint, LLC | Mar 25, 2026 | SESE |
| K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | Feb 13, 2026 | SESE |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | Jan 16, 2026 | SESE |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | Jan 15, 2026 | SESE |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | Jan 14, 2026 | SESE |
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | Jan 8, 2026 | SESE |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | Jan 6, 2026 | SESE |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. | Dec 19, 2025 | SESE |
| K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | Dec 5, 2025 | SESE |
| K250769 | Dakota LP System | Precision Spine, Inc. | Nov 24, 2025 | SESE |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | Nov 21, 2025 | SESE |
| K250560 | BEE HA | NGMedical GmbH | Nov 21, 2025 | SESE |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | Oct 10, 2025 | SESE |
Top Applicants
- Orthofix, Inc. — 9 clearances
- Nu Vasive, Incorporated — 8 clearances
- Gbs Commonwealth Co., Ltd. — 7 clearances
- Globus Medical, Inc. — 7 clearances
- Medtronic Sofamor Danek USA, Inc. — 7 clearances
