Clearance Summary
ORTHO ANCHOR SCREWS received FDA 510(k) clearance under submission number K073461, sponsored by Mis Implants Technologies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-01-25.
- Submission: K073461
- Applicant / Sponsor: Mis Implants Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2008-01-25
Classification & Regulation
This clearance is catalogued under FDA product code OAT and 21 CFR 872.3640, within the Dental review panel as a Class II device.