MODUS TRILOCK 2.0/2.3/2.5— 510(k) K071612

Substantially Equivalent

Medartis AG

FDA 510(k) clearance K071612 for MODUS TRILOCK 2.0/2.3/2.5, Substantially Equivalent on 2007-09-11. Applicant: Medartis AG.

Clearance details

Applicant: Medartis AG
Product code: Code JEY
Advisory panel: Dental
Date received: 2007-06-13
Decision date: 2007-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.