Ventana A Anterior Lumbar Interbody System
FDA 510(k) K253559 · Spinal Elements, Inc.
510(k) numberK253559
Submission
- Device name
- Ventana A Anterior Lumbar Interbody System
- Applicant
- Spinal Elements, Inc.
Carlsbad, CA, US - Received
- November 17, 2025
- Decision date
- February 25, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
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.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer SystemOVD · Traditional | Avalign Technologies, Inc. | 07/10/2025SE |
More from Avalign Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | 05/15/2026SE |
| K250773 | Luna® Ti Interbody Fusion SystemMAX · Traditional | 02/04/2026SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | 05/21/2025SE |
| K243916 | Primus Spinal Fixation SystemNKB · Traditional | 02/21/2025SE |
| K234150 | Lucent® XPMAX · Traditional | 03/27/2024SE |
| K231593 | Sapphire X3 Anterior Cervical Plate SystemKWQ · Traditional | 08/02/2023SE |
| K231252 | Ventana L Spinal SystemMAX · Traditional | 06/30/2023SE |
| K222833 | Ventana C Spinal SystemODP · Traditional | 05/19/2023SE |
| K222516 | Mercury® II Spinal SystemNKB · Traditional | 12/01/2022SE |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…MAX · Traditional | 06/30/2021SE |
Questions and answers
When was Ventana A Anterior Lumbar Interbody System cleared by the FDA?
Ventana A Anterior Lumbar Interbody System (K253559) received a 510(k) decision of Substantially Equivalent on February 25, 2026, 100 days after the submission was received.
What is the product code of K253559?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.