510(k) K151387

Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade by Stryker — Product Code HBW

K151387 is an FDA 510(k) premarket notification submitted by Stryker for the device "Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade". The FDA issued a decision of Substantially Equivalent on June 24, 2015. The device falls under product code HBW (Fastener, Plate, Cranioplasty), a Class II device regulated under 21 CFR 882.5360. Stryker has at least 10 other 510(k) clearances on record.