K243190
- 510(k) number
- K243190
- Device name
- USTOMED Bone Fixation/Bone Augmentation Systems - PIN
- Applicant
- Ustomed Instrumente Ulrich Storz GmbH & Co. KG DE
- Product code
- DZL — Screw, Fixation, Intraosseous
- Decision date
- 2025-06-27
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243190.pdf
Official FDA record: K243190
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.