Axis Spine Technologies ALIF— 510(k) K210590

Name: FDA 510(k) clearance K210590
Creator: U.S. Food and Drug Administration
Published: 2021-09-29

Substantially Equivalent

Axis Spine Technologies, Ltd.

FDA 510(k) clearance K210590 for Axis Spine Technologies ALIF, Substantially Equivalent on 2021-09-29. Applicant: Axis Spine Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Axis Spine Technologies, Ltd.
Product code: Product code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2021-03-01
Decision date: 2021-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Albans, GB

Download summary PDF View on FDA.gov ↗

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K200352 — Axis Spine Technologies ALIF2020-05-20

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.