Product code ODP
- Device name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3080
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-05-16 |
| K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | 2026-05-12 |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | 2026-04-24 |
| K253260 | ORIO-3D Cage System | SpineCraft | 2026-04-16 |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | 2026-04-13 |
| K242303 | MOD-C | Orthomod, LLC | 2026-04-01 |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026-03-30 |
| K252432 | Flex-Z™ Cervical Cage | Spinepoint, LLC | 2026-03-25 |
| K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | 2026-02-13 |
| 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. | 2026-01-16 |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026-01-15 |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026-01-14 |
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | 2026-01-08 |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026-01-06 |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025-12-19 |
| K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | 2025-12-05 |
| K250769 | Dakota LP System | Precision Spine, Inc. | 2025-11-24 |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 2025-11-21 |
| K250560 | BEE HA | NGMedical GmbH | 2025-11-21 |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | 2025-10-10 |
| K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025-08-29 |
| K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025-07-03 |
| K250605 | EVOL® ha – Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | 2025-03-12 |
| K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | 2025-02-18 |
| K243673 | Xenco Medical CancelleX Cervical Interbody System | Xenco Medical, LLC | 2025-01-29 |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024-11-15 |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab | 2024-11-07 |
| K242195 | Gemini Cervical Fusion Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2024-11-04 |
| K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | 2024-08-20 |
| K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | 2024-06-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810017915385 | Saber-C, Spike Driver 8-9, Lateral | ELEVATION SPINE, INC. | 2026-06-05 |
| 00810017915378 | Saber-C, Spike Driver 8-9, Medial | ELEVATION SPINE, INC. | 2026-06-05 |
| 00810017915361 | Saber-C, Spike Driver 5-7, Lateral | ELEVATION SPINE, INC. | 2026-06-05 |
| 00810017915354 | Saber-C, Spike Driver 5-7, Medial | ELEVATION SPINE, INC. | 2026-06-05 |
| 00810017914623 | Saber-C Plate, 14x17x8 12 deg. | ELEVATION SPINE, INC. | 2026-06-05 |
| 00810017914616 | Saber-C Plate, 14x17x7 12 deg. | ELEVATION SPINE, INC. | 2026-06-05 |
| 00810017914609 | Saber-C Plate, 14x17x6 12 deg. | ELEVATION SPINE, INC. | 2026-06-05 |
| 00810017913664 | Saber-C Body (PT), 12x15x7 6 deg. | ELEVATION SPINE, INC. | 2026-06-05 |
| 00841732162785 | VALEO | CTL Medical Corporation | 2023-09-30 |
| 00841732162778 | VALEO | CTL Medical Corporation | 2023-09-30 |
| 00841732162761 | VALEO | CTL Medical Corporation | 2023-09-30 |
| 00841732145627 | VALEO II C Interbody Fusion System | CTL Medical Corporation | 2023-09-27 |
| 00841732145610 | VALEO II C Interbody Fusion System | CTL Medical Corporation | 2023-09-27 |
| 00841732144378 | VALEO II C Interbody Fusion System | CTL Medical Corporation | 2023-09-27 |
| 00841732144361 | VALEO II C Interbody Fusion System | CTL Medical Corporation | 2023-09-27 |
| 00841732160217 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732155008 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154988 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154971 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154964 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154933 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154926 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154919 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154902 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154896 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154889 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732154872 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732145566 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732145559 | VALEO C+CSC with Lumen Interbody Fusion Device | CTL Medical Corporation | 2023-09-19 |
| 00841732144460 | VALEO II C Interbody Fusion System | CTL Medical Corporation | 2023-07-26 |