STOMA BONE BLOCK SCREW— 510(k) K080430

Name: FDA 510(k) clearance K080430
Creator: U.S. Food and Drug Administration
Published: 2008-11-21

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. Device class: 2.

Clearance details

Applicant: Storz AM Mark GmbH
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 2008-02-19
Decision date: 2008-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emmingen-Liptingen, DE

Download summary PDF View on FDA.gov ↗

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K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN2025-06-27
K233419 — GBR System2025-01-03

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K051871 — STOMA BONE SCREW2005-10-27

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.