GALILEOS IMPLANT, V 1.0— 510(k) K061472

Substantially Equivalent

Sicat GmbH & Co. KG

FDA 510(k) clearance K061472 for GALILEOS IMPLANT, V 1.0, Substantially Equivalent on 2006-06-09. Applicant: Sicat GmbH & Co. KG.

Clearance details

Applicant: Sicat GmbH & Co. KG
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-05-30
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonn, DE

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.