USTOMED Bone Fixation/Bone Augmentation Systems - PIN— 510(k) K243190
Substantially EquivalentUstomed Instrumente Ulrich Storz GmbH & Co. KG
FDA 510(k) clearance K243190 for USTOMED Bone Fixation/Bone Augmentation Systems - PIN, Substantially Equivalent on 2025-06-27. Applicant: Ustomed Instrumente Ulrich Storz GmbH & Co. KG.
Clearance details
- Applicant
- Ustomed Instrumente Ulrich Storz GmbH & Co. KG
- Product code
- Code DZL
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
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.