OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II
FDA product code OVD covers "Intervertebral Fusion Device With Integrated Fixation, Lumbar", a Class II medical device regulated under 21 CFR 888.3080. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K262025 | Inno Holdings Inc. Dba Innovasis | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis | Sep 11, 2026 |
| K261408 | Elevation Spine | SABER-XA System | Aug 3, 2026 |
| K261809 | Foundation Surgical Group | Interwedge® Standalone Lateral | Jul 31, 2026 |
| K261353 | Kyocera Medical Technologies | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lum | Jul 15, 2026 |
| K260810 | Tyber Medical | Anteralign LS coverplate | Jun 10, 2026 |
| K254202 | Medacta International | MectaLIF 3D Metal Anterior | May 5, 2026 |
| K253401 | Globus Medical | SCRIPT Implant System | Apr 29, 2026 |
| K253559 | Spinal Elements | Ventana A Anterior Lumbar Interbody System | Feb 25, 2026 |
| K251829 | Degen Medical | DeGen Medical Patient Specific Implant (PSI) System | Dec 8, 2025 |
| K251575 | Alphatec Spine | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interb | Sep 3, 2025 |
| K250072 | Avalign Technologies | CONDUIT SYNFIX Evolution Secured Spacer System | Jul 10, 2025 |
| K251644 | Pro Surgical | ProAM ALIF System | Jun 24, 2025 |
| K250845 | Curiteva | Curiteva Porous PEEK Standalone ALIF System | Jun 18, 2025 |
| K251459 | Novapproach Spine | OneLIF Interbody Fusion System | Jun 12, 2025 |
| K243934 | Nexus Spine | Stable-L Lumbar Interbody System | Apr 30, 2025 |
| K243386 | Acuity Surgical Devices | Ventris Intervertebral Body Fusion Device | Apr 22, 2025 |
| K250603 | Innovasis | AxTiHA® Stand-Alone ALIF System | Mar 24, 2025 |
| K243802 | Carlsmed | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lu | Mar 17, 2025 |
| K243635 | Carlsmed | aprevo® anterior lumbar interbody fusion device with interfixation | Dec 13, 2024 |
| K243191 | Atlas Spine | Atlas Spine Lateral Expandable Interbody System | Nov 26, 2024 |