ODP — Intervertebral Fusion Device With Bone Graft, Cervical Class II
FDA product code ODP covers "Intervertebral Fusion Device With Bone Graft, Cervical", a Class II medical device regulated under 21 CFR 888.3080. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ODP
- Device Class
- Class II
- Regulation Number
- 888.3080
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262061 | stryker spine | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po | July 17, 2026 |
| K254130 | c.a. medical | C.A. Medical Interbody Fusion System | July 8, 2026 |
| K260840 | l and k biomed co | BluEX Cervical Expandable Cage System | May 16, 2026 |
| K260850 | osteomni | OSTEOMNI SPINAL CAGES SYSTEM | May 12, 2026 |
| K260549 | zsfab | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | April 24, 2026 |
| K253260 | spinecraft | ORIO-3D Cage System | April 16, 2026 |
| K260340 | hc biologics | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, | April 13, 2026 |
| K242303 | orthomod | MOD-C | April 1, 2026 |
| K252240 | spectrum spine | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | March 30, 2026 |
| K252432 | spinepoint | Flex-Z Cervical Cage | March 25, 2026 |
| K254105 | nanohive medical | Hive Standalone Cervical System and Hive C Interbody System | February 13, 2026 |
| K252205 | curiteva | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte | January 16, 2026 |
| K254061 | curiteva | Curiteva Porous PEEK Cervical Interbody Fusion System | January 15, 2026 |
| K252219 | sync surgical | Cervical Interbody and VBR Fusion System | January 14, 2026 |
| K252711 | intelivation technologies | Advantage-C Ti3D Cervical Interbody Fusion Device | January 8, 2026 |
| K252894 | carlsmed | aprevo® cervical interbody system | January 6, 2026 |
| K252781 | mikron makina sanayi ve tic. ltd. sti | MSFX MIKRON PEEK CAGES | December 19, 2025 |
| K250764 | lincotek medical | SpineLinc Anterior Cervical Implant System | December 5, 2025 |
| K250769 | precision spine | Dakota LP System | November 24, 2025 |
| K250560 | ngmedical | BEE HA | November 21, 2025 |