GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW— 510(k) K083567

Name: FDA 510(k) clearance K083567
Creator: U.S. Food and Drug Administration
Published: 2009-09-14

Substantially Equivalent

Co-Ligne AG

FDA 510(k) clearance K083567 for GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW, Substantially Equivalent on 2009-09-14. Applicant: Co-Ligne AG. Device class: 2.

Clearance details

Applicant: Co-Ligne AG
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2008-12-03
Decision date: 2009-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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K162143 — FixxSure® X-Link2016-09-23
K161151 — Spinal fixation system2016-09-21
K162189 — ANAX 5.5 Spinal System2016-08-30

More clearances from Co-Ligne AG

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K072326 — OSTAPEK VBR SYSTEM2008-06-24
K051089 — GII SPINAL FIXATION SYSTEM2005-10-26
K032604 — GII SPINAL FIXATION SYSTEM2004-01-20

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.