SICAT IMPLANT— 510(k) K090119

Substantially Equivalent

Sicat GmbH & Co. KG

FDA 510(k) clearance K090119 for SICAT IMPLANT, Substantially Equivalent on 2009-02-05. Applicant: Sicat GmbH & Co. KG.

Clearance details

Applicant
Sicat GmbH & Co. KG
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bonn, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . 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.