STOMA BONE BLOCK SCREW— 510(k) K080430

Substantially Equivalent

Storz AM Mark GmbH

FDA 510(k) clearance K080430 for STOMA BONE BLOCK SCREW, Substantially Equivalent on 2008-11-21. Applicant: Storz AM Mark GmbH.

Clearance details

Applicant
Storz AM Mark GmbH
Product code
Code DZL
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Emmingen-Liptingen, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code DZL

product code DZL
Injury
168
Total
168

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.