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 |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. | 2026-08-26 |
| K262489 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-08-18 |
| K253041 | 3d Cage Cervical | Fims Co., Ltd. | 2026-07-23 |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer... | Stryker Spine | 2026-07-17 |
| K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026-07-08 |
| 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 |
| K250560 | BEE HA | NGMedical GmbH | 2025-11-21 |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810017915163 | SABER-XA, Screw Ø5.5 x 27.5 | ELEVATION SPINE, INC. | 2026-09-22 |
| 00810017915156 | SABER-XA, Screw Ø5.5 x 22.5 | ELEVATION SPINE, INC. | 2026-09-22 |
| 00810017915149 | SABER-XA, Screw Ø5.0 x 32.5 | ELEVATION SPINE, INC. | 2026-09-22 |
| 00810017915125 | SABER-XA, Screw Ø5.0 x 22.5 | ELEVATION SPINE, INC. | 2026-09-22 |
| 10888857461819 | CASCADIA™ Interbody System | VB Spine LLC | 2019-10-31 |
| 10888857461888 | CASCADIA™ Interbody System | VB Spine LLC | 2019-10-31 |
| 10888857218963 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 10888857218772 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 10888857219595 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 10888857219489 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 10888857219076 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 07613154261420 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261413 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261406 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261390 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261383 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261376 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261369 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261352 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261345 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261338 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261321 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261314 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261307 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261291 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261284 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261277 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261260 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261253 | AVS AS | Stryker Corporation | 2015-09-14 |
| 07613154261246 | AVS AS | Stryker Corporation | 2015-09-14 |