510(k) K210099

Meticuly Patient-Specific Titanium Mesh Implant by Meticuly Co., Ltd. — Product Code GXN

K210099 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 December 21, 2021. 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.