Product code OVD: 510(k) clearances and predicates
Product code OVD covers Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System. FDA lists 205 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
205 clearances on file under product code OVD. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 14 |
| 2023 | 12 |
| 2024 | 12 |
| 2025 | 10 |
| 2026 so far | 8 |
Recent clearances
Newest OVD clearances in the FDA index, with applicant and decision date:
- K262025, Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System, applicant INNO Holdings Inc. DBA Innovasis, decided 2026-09-11. FDA record
- K261408, SABER-XA System, applicant Elevation Spine, decided 2026-08-03. FDA record
- K261809, Interwedge® Standalone Lateral, applicant Foundation Surgical Group, decided 2026-07-31. FDA record
- K261353, Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System, applicant Kyocera Medical Technologies, Inc., decided 2026-07-15. FDA record
- K260810, Anteralign LS coverplate, applicant Tyber Medical, LLC, decided 2026-06-10. FDA record
- K254202, MectaLIF 3D Metal Anterior, applicant Medacta International S.A., decided 2026-05-05. FDA record
- K253401, SCRIPT Implant System, applicant Globus Medical, Inc., decided 2026-04-29. FDA record
- K253559, Ventana A Anterior Lumbar Interbody System, applicant Spinal Elements, Inc., decided 2026-02-25. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include SABER-XA System, Interwedge® Standalone Lateral. Watch new OVD clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code OVD?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent OVD clearances include Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System.
How many 510(k) clearances use product code OVD?
205 at the time this page was generated, from openFDA records.
How do I find a predicate device under OVD?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new OVD clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.