Clearance Summary
INLIANT Surgical Navigation System received FDA 510(k) clearance under submission number K213392, sponsored by Navigate Surgical Technologies, 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 2022-02-22.
- Submission: K213392
- Applicant / Sponsor: Navigate Surgical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2022-02-22
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.