510(k) K220357

MedCAD AccuShape Titanium Patient-Specific Cranial Implant by Medcad — Product Code GXN

K220357 is an FDA 510(k) premarket notification submitted by Medcad for the device "MedCAD AccuShape Titanium Patient-Specific Cranial Implant". The FDA issued a decision of Substantially Equivalent on August 26, 2022. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Medcad has at least 8 other 510(k) clearances on record.