510(k) K161446

Biopor Porous Polyethylene Implants by Ceremed , Inc. — Product Code GWO

K161446 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "Biopor Porous Polyethylene Implants". The FDA issued a decision of Substantially Equivalent on September 27, 2016. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Ceremed , Inc. has at least 10 other 510(k) clearances on record.