Clearance Summary
BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM received FDA 510(k) clearance under submission number K091051, sponsored by Tita-Link. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-12-08.
- Submission: K091051
- Applicant / Sponsor: Tita-Link
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2009-12-08
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.