AxTiHA® Stand-Alone ALIF System— 510(k) K250603

Name: FDA 510(k) clearance K250603
Creator: U.S. Food and Drug Administration
Published: 2025-03-24

Substantially Equivalent

Innovasis

FDA 510(k) clearance K250603 for AxTiHA® Stand-Alone ALIF System, Substantially Equivalent on 2025-03-24. Applicant: Innovasis. Device class: 2.

Clearance details

Applicant: Innovasis
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-02-28
Decision date: 2025-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

view all

K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10

More clearances from Innovasis

view all

K250076 — Endeavor Stand-Alone Cervical IBF System2025-09-25

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.