510(k) K253206

METICULY Patient-specific CMF solution by Meticuly Co., Ltd. — Product Code JEY

K253206 is an FDA 510(k) premarket notification submitted by Meticuly Co., Ltd. for the device "METICULY Patient-specific CMF solution". The FDA issued a decision of Substantially Equivalent on July 25, 2026. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Meticuly Co., Ltd. has at least 3 other 510(k) clearances on record.