510(k) K152463

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant by Poriferous, LLC — Product Code FWP

K152463 is an FDA 510(k) premarket notification submitted by Poriferous, LLC for the device "SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant". The FDA issued a decision of Substantially Equivalent on January 20, 2016. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Poriferous, LLC has at least 1 other 510(k) clearance on record.