OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II
Classification Details
- Product Code
- OVD
- Device Class
- Class II
- Regulation Number
- 888.3080
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253559 | spinal elements | Ventana A Anterior Lumbar Interbody System | February 25, 2026 |
| K251829 | degen medical | DeGen Medical Patient Specific Implant (PSI) System | December 8, 2025 |
| K251575 | alphatec spine | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interb | September 3, 2025 |
| K250072 | avalign technologies | CONDUIT SYNFIX Evolution Secured Spacer System | July 10, 2025 |
| K251644 | pro surgical | ProAM ALIF System | June 24, 2025 |
| K250845 | curiteva | Curiteva Porous PEEK Standalone ALIF System | June 18, 2025 |
| K251459 | novapproach spine | OneLIF Interbody Fusion System | June 12, 2025 |
| K243934 | nexus spine | Stable-L Lumbar Interbody System | April 30, 2025 |
| K243386 | acuity surgical devices | Ventris Intervertebral Body Fusion Device | April 22, 2025 |
| K250603 | innovasis | AxTiHA® Stand-Alone ALIF System | March 24, 2025 |
| K243802 | carlsmed | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lu | March 17, 2025 |
| K243635 | carlsmed | aprevo® anterior lumbar interbody fusion device with interfixation | December 13, 2024 |
| K243191 | atlas spine | Atlas Spine Lateral Expandable Interbody System | November 26, 2024 |
| K241077 | degen medical | DeGen Medical Patient Specific Implant (PSI) System | October 29, 2024 |
| K241992 | medtronic sofamor danek usa | Catalyft LS Expandable Interbody System | October 28, 2024 |
| K241477 | carlsmed | aprevo® anterior lumbar interbody fusion device with interfixation | October 9, 2024 |
| K241487 | foundation surgical group | Interwedge® Standalone Lateral | October 2, 2024 |
| K241321 | spineart | Juliet® Ti LL Lumbar Interbody Device | July 18, 2024 |
| K240368 | evolution spine | E3D-A Interbody System | May 15, 2024 |
| K240126 | pro surgical | ProAM ALIF System | May 3, 2024 |