510(k) K172034

Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap by Stryker Corporation — Product Code OLO

K172034 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap". The FDA issued a decision of Substantially Equivalent on Oct 18, 2017. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Stryker Corporation has 80 other 510(k) clearances on record.