GMK HINGE— 510(k) K130299

Substantially Equivalent

Medacta International

FDA 510(k) clearance K130299 for GMK HINGE, Substantially Equivalent on 2013-08-15. Applicant: Medacta International.

Clearance details

Applicant: Medacta International
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2013-02-07
Decision date: 2013-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.