OVE
- Product code
- OVE
- Device name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3080
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 33
- Summaries archived here
- 28 (direct download)
- 510(k) clearances (all years, FDA)
- 166 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (33)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261882 | 2026-08-21 | Osseus Fusions Systems, LLC | Pisces-SC Standalone Cervical Interbody System | FDA |
| K261451 | 2026-07-31 | ZSFab, Inc. | ZSAlign Cervical Interbody System | |
| K262094 | 2026-07-22 | Evolution Spine | E3D-C Interbody System | |
| K261279 | 2026-06-22 | Nexus Spine | DeltaNEC Interbody System | |
| K252982 | 2026-06-18 | Avalign Technologies, Inc. | CONDUIT ZERO-P VA Secured Spacer System | FDA |
| K260036 | 2026-06-15 | Medyssey Co, Ltd. | NeckTune 3D SA Cervical Cage | |
| K260660 | 2026-04-27 | Elevation Spine | SABER-C System | |
| K253213 | 2026-04-20 | ZheJiang Decans Medical Devices Co., L… | SAGI Cervical Cage System | |
| K252774 | 2026-04-15 | ZheJiang Decans Medical Devices Co., L… | Uni-C Cervical Cage System | |
| K260038 | 2026-02-04 | Evolution Spine | E3D-C Interbody System | |
| K253876 | 2025-12-22 | Globus Medical, Inc. | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | |
| K253200 | 2025-12-11 | 4Web Medical, Inc. | Cervical Spine Truss System - Stand Alone (CSTS-SA) | FDA |
| K250076 | 2025-09-25 | Innovasis | Endeavor Stand-Alone Cervical IBF System | |
| K250540 | 2025-08-08 | Elevation Spine | SABER-C System | |
| K251735 | 2025-07-30 | Acuity Surgical Devices, LLC | Stabilis SA Cervical Stand-Alone System (Various PNs… | |
| K251431 | 2025-06-27 | Jeil Medical Corporation | FIX-C PEEK ACIF SA System | |
| K251117 | 2025-04-25 | 4Web Medical | Cervical Spine Truss System (CSTS) | FDA |
| K242928 | 2025-04-10 | Kyocera Medical Technologies, Inc. | Tesera-k SC System | |
| K243188 | 2025-02-11 | Signus Medizintechnik GmbH | CYLOX® ST | |
| K242483 | 2025-02-07 | Genesys Spine | Genesys Spine AIS-C II Cervical Interbody Fusion Sys… | |
| K242517 | 2024-11-20 | Pro Surgical, Inc. | ProAM ACDF System | |
| K241846 | 2024-08-12 | Evolution Spine | E3D-C Interbody System | |
| K241467 | 2024-07-17 | Nexus Spine, LLC | Stable-C Interbody System | |
| K240699 | 2024-05-10 | Spineart SA | SCARLET® AC-Ti | |
| K234119 | 2024-04-19 | Innosys Co., Ltd. | UniSpace® Stand-Alone C Cage | |
| K240715 | 2024-03-22 | Clariance | Idys® C ZP 3DTi | |
| K233594 | 2023-12-13 | Genesys Spine | Genesys Spine 3DP AIS-C II Cervical Interbody System | |
| K233414 | 2023-11-28 | SeaSpine Orthopedics Corporation | Shoreline ACS Interbody System; Shoreline RT Interbo… | |
| K233191 | 2023-11-21 | Spinal Analytics & Geometrical Implant… | TotalTi ACDF by SAGICO | FDA |
| K232348 | 2023-10-27 | MiRus, LLC | RIGEL 3DR Standalone Anterior Cervical Interbody Fu… | |
| K231704 | 2023-10-19 | Life Spine, Inc. | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer Syste… | |
| K231739 | 2023-09-25 | 4Web Medical, Inc. | Cervical Spine Truss System (CSTS) | |
| K223869 | 2023-09-14 | Choice Spine, LLC | ChoiceSpine Blackhawk Ti Cervical Spacer System |
Official FDA classification page: OVE
Classification and pathway per current FDA publications. Data from openFDA (CC0).