Implantcast ic-Bipolar Head System— 510(k) K191569

Substantially Equivalent

Implantcast GmbH

FDA 510(k) clearance K191569 for Implantcast ic-Bipolar Head System, Substantially Equivalent on 2019-08-28. Applicant: Implantcast GmbH.

Clearance details

Applicant: Implantcast GmbH
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2019-06-13
Decision date: 2019-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buxtehude, DE

Download summary PDF View on FDA.gov ↗

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.