Clearance Summary
Stryker Upper-Face AXS screws and Mid-Face AXS screws received FDA 510(k) clearance under submission number K172572, sponsored by Stryker. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-10-31.
- Submission: K172572
- Applicant / Sponsor: Stryker
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2017-10-31
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.