GMK Revision Femoral Distal Augmentation— 510(k) K163311

Name: FDA 510(k) clearance K163311
Creator: U.S. Food and Drug Administration
Published: 2016-12-21

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K163311 for GMK Revision Femoral Distal Augmentation, Substantially Equivalent on 2016-12-21. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 2016-11-23
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

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K242871 — ATTUNE Revision Hinge Knee2024-11-21

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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.