510(k) K231834

VSP PEEK Cranial Implant by 3D Systems, Inc. — Product Code GWO

K231834 is an FDA 510(k) premarket notification submitted by 3D Systems, Inc. for the device "VSP PEEK Cranial Implant". The FDA issued a decision of Substantially Equivalent on April 4, 2024. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. 3D Systems, Inc. has at least 10 other 510(k) clearances on record.