Optimus ALIF System— 510(k) K160291

Name: FDA 510(k) clearance K160291
Creator: U.S. Food and Drug Administration
Published: 2016-02-18

Substantially Equivalent

Amendia, Inc.

FDA 510(k) clearance K160291 for Optimus ALIF System, Substantially Equivalent on 2016-02-18. Applicant: Amendia, Inc.. Device class: 2.

Clearance details

Applicant: Amendia, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2016-02-03
Decision date: 2016-02-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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K260810 — Anteralign LS coverplate2026-06-10

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K153152 — Syzygy Stabilization System2016-04-27
K152972 — Amendia Stand-Alone Cervical System2016-01-14

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.