MEDACTA BIPOLAR HEAD— 510(k) K091967

Name: FDA 510(k) clearance K091967
Creator: U.S. Food and Drug Administration
Published: 2010-03-02

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K091967 for MEDACTA BIPOLAR HEAD, Substantially Equivalent on 2010-03-02. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
Advisory panel: Orthopedic
Date received: 2009-07-01
Decision date: 2010-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.