K210010

Substantially Equivalent

GMK Revision & Hinge Extension - TiNbN Coating

Applicant: Medacta International S.A.
Product 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

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.