Clearance Summary
USTOMED Bone Fixation/Bone Augmentation Systems - PIN received FDA 510(k) clearance under submission number K243190, sponsored by Ustomed Instrumente Ulrich Storz GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-06-27.
- Submission: K243190
- Applicant / Sponsor: Ustomed Instrumente Ulrich Storz GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 2025-06-27
Classification & Regulation
This clearance is catalogued under FDA product code DZL and 21 CFR 872.4880, within the Dental review panel as a Class II device.