510(k) K232771

Montage Flowable Settable, Resorbable Bone Paste by Orthocon, Inc. — Product Code GXP

K232771 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "Montage Flowable Settable, Resorbable Bone Paste". The FDA issued a decision of Substantially Equivalent on February 16, 2024. 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.