510(k) K190229

Stryker PEEK Customized Cranial Implant Kit by Stryker — Product Code GWO

K190229 is an FDA 510(k) premarket notification submitted by Stryker for the device "Stryker PEEK Customized Cranial Implant Kit". The FDA issued a decision of Substantially Equivalent on July 11, 2019. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Stryker has at least 10 other 510(k) clearances on record.