510(k) K161090

Cranial PSI by Ossdsign AB — Product Code GXN

K161090 is an FDA 510(k) premarket notification submitted by Ossdsign AB for the device "Cranial PSI". The FDA issued a decision of Substantially Equivalent on January 19, 2017. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Ossdsign AB has at least 5 other 510(k) clearances on record.