GMK Revision & Hinge Extension - TiNbN Coating— 510(k) K210010

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K210010 for GMK Revision & Hinge Extension - TiNbN Coating, Substantially Equivalent on 2021-03-02. Applicant: Medacta International S.A..

Clearance details

Applicant: Medacta International S.A.
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2021-01-04
Decision date: 2021-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro (Ch), CH

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.