Clearance Summary
Stryker OrthoMap Precision Knee system received FDA 510(k) clearance under submission number K162341, sponsored by Stryker Leibinger GmbH & Co KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-10-12.
- Submission: K162341
- Applicant / Sponsor: Stryker Leibinger GmbH & Co KG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2016-10-12
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.