510(k) K251959

TnR Cranial Implant by T&R BIOFAB CO., Ltd. — Product Code GXP

K251959 is an FDA 510(k) premarket notification submitted by T&R BIOFAB CO., Ltd. for the device "TnR Cranial Implant". The FDA issued a decision of Substantially Equivalent on July 30, 2026. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. T&R BIOFAB CO., Ltd. has at least 1 other 510(k) clearance on record.