AxTiHA Stand-Alone ALIF System— 510(k) K212967

Name: FDA 510(k) clearance K212967
Creator: U.S. Food and Drug Administration
Published: 2021-10-15

Substantially Equivalent

Innovasis, Inc.

FDA 510(k) clearance K212967 for AxTiHA Stand-Alone ALIF System, Substantially Equivalent on 2021-10-15. Applicant: Innovasis, Inc.. Device class: 2.

Clearance details

Applicant: Innovasis, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2021-09-16
Decision date: 2021-10-15
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

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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

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K231899 — HAtetracell-C Titanium Cervical IBF System2023-10-17
K223511 — Excella Navigation Instruments2023-05-02

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.