510(k) K103352— VERSAFITCUP CC TRIO

Substantially Equivalent

Medacta International

Clearance details

Applicant: Medacta International
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2010-11-16
Decision date: 2011-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.