510(k) K231475

MONTAGE-QS Settable, Resorbable Bone Putty by Orthocon, Inc. — Product Code GXP

K231475 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "MONTAGE-QS Settable, Resorbable Bone Putty". The FDA issued a decision of Substantially Equivalent on October 12, 2023. 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.