Clearance Summary
X-Guide® Surgical Navigation System received FDA 510(k) clearance under submission number K200662, sponsored by X-Nav Technologies, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-05-21.
- Submission: K200662
- Applicant / Sponsor: X-Nav Technologies, LLC
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2020-05-21
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.