OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical Class II
FDA product code OVE covers "Intervertebral Fusion Device With Integrated Fixation, 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
- OVE
- 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 with or without supplemental fixation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261279 | nexus spine | DeltaNEC Interbody System | June 22, 2026 |
| K252982 | avalign technologies | CONDUIT ZERO-P VA Secured Spacer System | June 18, 2026 |
| K260036 | medyssey co | NeckTune 3D SA Cervical Cage | June 15, 2026 |
| K260660 | elevation spine | SABER-C System | April 27, 2026 |
| K253213 | zhejiang decans medical devices co | SAGI Cervical Cage System | April 20, 2026 |
| K252774 | zhejiang decans medical devices co | Uni-C Cervical Cage System | April 15, 2026 |
| K260038 | evolution spine | E3D-C Interbody System | February 4, 2026 |
| K253876 | globus medical | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | December 22, 2025 |
| K253200 | 4web medical | Cervical Spine Truss System - Stand Alone (CSTS-SA) | December 11, 2025 |
| K250076 | innovasis | Endeavor Stand-Alone Cervical IBF System | September 25, 2025 |
| K250540 | elevation spine | SABER-C System | August 8, 2025 |
| K251735 | acuity surgical devices | Stabilis SA Cervical Stand-Alone System (Various PNs) | July 30, 2025 |
| K251431 | jeil medical corporation | FIX-C PEEK ACIF SA System | June 27, 2025 |
| K251117 | 4web medical | Cervical Spine Truss System (CSTS) | April 25, 2025 |
| K242928 | kyocera medical technologies | Tesera-k SC System | April 10, 2025 |
| K243188 | signus medizintechnik | CYLOX® ST | February 11, 2025 |
| K242483 | genesys spine | Genesys Spine AIS-C II Cervical Interbody Fusion System | February 7, 2025 |
| K242517 | pro surgical | ProAM ACDF System | November 20, 2024 |
| K241846 | evolution spine | E3D-C Interbody System | August 12, 2024 |
| K241467 | nexus spine | Stable-C Interbody System | July 17, 2024 |