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 |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | INNO Holdings Inc. DBA Innovasis | 2026-09-11 |
| K261408 | SABER-XA System | Elevation Spine | 2026-08-03 |
| K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | 2026-07-31 |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. | 2026-07-15 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10889981214661 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214883 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214876 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214869 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214852 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214845 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214838 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214821 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214739 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214722 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214715 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214708 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214692 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214685 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214678 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214395 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214654 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214647 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214630 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214623 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214616 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214487 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214470 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214463 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214456 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214449 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214432 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214425 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214418 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |
| 10889981214401 | Meridian | Seaspine Orthopedics Corporation | 2020-12-30 |