Clearance Summary
Navigated T2 STRATOSPHERE Inserters and Navigated Templates received FDA 510(k) clearance under submission number K191039, sponsored by Medtronic Sofamor Danek USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-08-26.
- Submission: K191039
- Applicant / Sponsor: Medtronic Sofamor Danek USA, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2019-08-26
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.