OVD
- Product code
- OVD
- Device name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- 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)
- 204
FDA classification definition
Intended to stabilize lumbar 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 (34)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261408 | 2026-08-03 | Elevation Spine | SABER-XA System | |
| K261809 | 2026-07-31 | Foundation Surgical Group | Interwedge® Standalone Lateral | |
| K261353 | 2026-07-15 | Kyocera Medical Technologies, Inc. | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) Sys | |
| K260810 | 2026-06-10 | Tyber Medical, LLC | Anteralign LS coverplate | |
| K254202 | 2026-05-05 | Medacta International S.A. | MectaLIF 3D Metal Anterior | FDA |
| K253401 | 2026-04-29 | Globus Medical, Inc. | SCRIPT Implant System | |
| K253559 | 2026-02-25 | Spinal Elements, Inc. | Ventana A Anterior Lumbar Interbody System | |
| K251829 | 2025-12-08 | Degen Medical | DeGen Medical Patient Specific Implant (PSI) System | FDA |
| K251575 | 2025-09-03 | Alphatec Spine | IdentiTi II ALIF Standalone Interbody System; Trans | |
| K250072 | 2025-07-10 | Avalign Technologies, Inc. | CONDUIT SYNFIX Evolution Secured Spacer System | |
| K251644 | 2025-06-24 | Pro Surgical, Inc. | ProAM ALIF System | |
| K250845 | 2025-06-18 | Curiteva, Inc. | Curiteva Porous PEEK Standalone ALIF System | |
| K251459 | 2025-06-12 | Novapproach Spine, LLC | OneLIF Interbody Fusion System | |
| K243934 | 2025-04-30 | Nexus Spine, LLC | Stable-L Lumbar Interbody System | |
| K243386 | 2025-04-22 | Acuity Surgical Devices, LLC | Ventris Intervertebral Body Fusion Device | |
| K250603 | 2025-03-24 | Innovasis | AxTiHA® Stand-Alone ALIF System | |
| K243802 | 2025-03-17 | Carlsmed, Inc. | aprevo® anterior and lateral lumbar interbody fusion | |
| K243635 | 2024-12-13 | Carlsmed, Inc. | aprevo® anterior lumbar interbody fusion device with | |
| K243191 | 2024-11-26 | Atlas Spine, Inc. | Atlas Spine Lateral Expandable Interbody System | — |
| K241077 | 2024-10-29 | Degen Medical | DeGen Medical Patient Specific Implant (PSI) System | FDA |
| K241992 | 2024-10-28 | Medtronic Sofamor Danek USA, Inc. | Catalyft LS Expandable Interbody System | |
| K241477 | 2024-10-09 | Carlsmed, Inc. | aprevo® anterior lumbar interbody fusion device with | |
| K241487 | 2024-10-02 | Foundation Surgical Group, Inc. | Interwedge® Standalone Lateral | |
| K241321 | 2024-07-18 | Spineart SA | Juliet® Ti LL Lumbar Interbody Device | |
| K240368 | 2024-05-15 | Evolution Spine | E3D-A Interbody System | |
| K240126 | 2024-05-03 | Pro Surgical, Inc. | ProAM ALIF System | |
| K240623 | 2024-04-24 | Omnia Medical, LLC | Omnia Medical TiBrid-SA System | |
| K233966 | 2024-04-22 | 4Web Medical, Inc. | Anterior Spine Truss System-Stand Alone (ASTS-SA) | |
| K232432 | 2024-01-30 | Evolution Spine | E3D-A Interbody System | |
| K232123 | 2023-10-18 | Medacta International S.A. | MectaLIF Anterior Lag Extension | |
| K231486 | 2023-10-12 | Nexus Spine, LLC | Stable-L Standalone Lumbar Interbody System | |
| K232097 | 2023-09-25 | Alphatec Spine, Inc. | IdentiTi ALIF Interbody Systems | |
| K232530 | 2023-09-18 | Nexus Spine, LLC | Stable-L Standalone Lumbar Interbody System, Stable- | FDA |
| K232154 | 2023-09-11 | MiRus, LLC | MiRus 3DR Lateral Lumbar Interbody Fusion System wit |
Official FDA classification page: OVD
Classification and pathway per current FDA publications. Data from openFDA (CC0).