Clearance Summary
ARCHITEX SPACE MAINTENANCE SYSTEM received FDA 510(k) clearance under submission number K110259, sponsored by Medtronic Sofamor Danek USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-04-13.
- Submission: K110259
- Applicant / Sponsor: Medtronic Sofamor Danek USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2011-04-13
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.