510(k) K252958

METICULY Patient-specific titanium mesh implant by Meticuly Co., Ltd. — Product Code GXN

K252958 is an FDA 510(k) premarket notification submitted by Meticuly Co., Ltd. for the device "METICULY Patient-specific titanium mesh implant". The FDA issued a decision of Substantially Equivalent on January 14, 2026. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Meticuly Co., Ltd. has at least 2 other 510(k) clearances on record.