Product code OVD
- Device name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3080
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260810 | Anteralign LS coverplate | Tyber Medical, LLC | 2026-06-10 |
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026-05-05 |
| K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026-04-29 |
| K253559 | Ventana™ A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026-02-25 |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-12-08 |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | Alphatec Spine | 2025-09-03 |
| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025-07-10 |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025-06-24 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025-06-18 |
| K251459 | OneLIF™ Interbody Fusion System | Novapproach Spine, LLC | 2025-06-12 |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025-04-30 |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025-04-22 |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | 2025-03-24 |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2025-03-17 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024-12-13 |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | 2024-11-26 |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2024-10-29 |
| K241992 | Catalyft™ LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2024-10-28 |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024-10-09 |
| K241487 | Interwedge® Standalone Lateral | Foundation Surgical Group, Inc. | 2024-10-02 |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | Spineart SA | 2024-07-18 |
| K240368 | E3D™-A Interbody System | Evolution Spine | 2024-05-15 |
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024-05-03 |
| K240623 | Omnia Medical TiBrid™-SA System | Omnia Medical, LLC | 2024-04-24 |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | 2024-04-22 |
| K232432 | E3D™-A Interbody System | Evolution Spine | 2024-01-30 |
| K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | 2023-10-18 |
| K231486 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2023-10-12 |
| K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023-09-25 |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023-09-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B678525161S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525168S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251680 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525167S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251670 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525166S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251660 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525165S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251650 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525164S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251640 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525163S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251630 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525162S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251620 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251540 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251610 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525160S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251600 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525159S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251590 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525158S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525157S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525156S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525155S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B678525154S0 | Stable-L™ | NEXUS SPINE, L.L.C. | 2024-05-01 |
| B6785251580 | Stable-L™ | NEXUS SPINE, L.L.C. | 2023-05-31 |
| B6785251570 | Stable-L™ | NEXUS SPINE, L.L.C. | 2023-05-31 |
| B6785251560 | Stable-L™ | NEXUS SPINE, L.L.C. | 2023-05-31 |
| B6785251550 | Stable-L™ | NEXUS SPINE, L.L.C. | 2023-05-31 |