510(k) K253854

MONTAGE XT Cranial Cement by Orthocon, Inc. — Product Code GXP

K253854 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "MONTAGE XT Cranial Cement". The FDA issued a decision of Substantially Equivalent on January 2, 2026. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Orthocon, Inc. has at least 10 other 510(k) clearances on record.