510(k) K253116

3D MAC Titanium Cranial Plate (TCP) System by The Surgeon General, Department of the Army (TSG-DA) — Product Code GXN

K253116 is an FDA 510(k) premarket notification submitted by The Surgeon General, Department of the Army (TSG-DA) for the device "3D MAC Titanium Cranial Plate (TCP) System". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. The Surgeon General, Department of the Army (TSG-DA) has at least 1 other 510(k) clearance on record.