510(k) K171152

Stryker Universal Neuro III System AXS Screw by Stryker — Product Code HBW

K171152 is an FDA 510(k) premarket notification submitted by Stryker for the device "Stryker Universal Neuro III System AXS Screw". The FDA issued a decision of Substantially Equivalent on May 19, 2017. 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.