Clearance Summary
X-Guide Surgical Navigation System received FDA 510(k) clearance under submission number K150222, sponsored by X-Nav Technologies, 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 2015-10-08.
- Submission: K150222
- Applicant / Sponsor: X-Nav Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2015-10-08
Classification & Regulation
This clearance is catalogued under FDA product code PLV and 21 CFR 872.4120, within the Dental review panel as a Class II device.