510(k) K212194

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System by Stryker Corporation — Product Code HAW

K212194 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System". The FDA issued a decision of Substantially Equivalent on February 16, 2023. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Stryker Corporation has at least 10 other 510(k) clearances on record.