OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical Class II
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 |
|---|---|---|---|
| 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 |
| K240699 | spineart | SCARLET® AC-Ti | May 10, 2024 |