510(k) K133082

OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE by Osteosymbionics, LLC — Product Code GXN

K133082 is an FDA 510(k) premarket notification submitted by Osteosymbionics, LLC for the device "OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE". The FDA issued a decision of Substantially Equivalent on May 20, 2014. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Osteosymbionics, LLC has at least 3 other 510(k) clearances on record.