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

Substantially Equivalent

Co-Ligne AG

Clearance details

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

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.