Clearance Summary
NavSuite3 Kit received FDA 510(k) clearance under submission number K150301, sponsored by Stryker Leibinger GmbH & Co. KG - Navigation. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-07-08.
- Submission: K150301
- Applicant / Sponsor: Stryker Leibinger GmbH & Co. KG - Navigation
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2015-07-08
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.