Clearance Summary
ORTHOFIX SCREW received FDA 510(k) clearance under submission number K113650, sponsored by Bonafix Surgical and Dental Implants, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-10-03.
- Submission: K113650
- Applicant / Sponsor: Bonafix Surgical and Dental Implants, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2012-10-03
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.