ODP — Intervertebral Fusion Device With Bone Graft, Cervical Class II
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 |
|---|---|---|---|
| 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 |
| K252686 | effortmed | EffortMed PEEK Cages & Corpectomy Cages | November 21, 2025 |
| K250560 | ngmedical | BEE HA | November 21, 2025 |
| K252737 | degen medical | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | October 10, 2025 |
| K250335 | k and j consulting | IVA & AEON Cervical and Lumbar Cage System | August 29, 2025 |
| K251080 | alphatec spine | IdentiTi II Cervical Interbody System | July 3, 2025 |
| K250605 | cutting edge spine | EVOL® ha Hyper C Cervical Interbody Fusion System | March 12, 2025 |