510(k) K253732

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

K253732 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "Permatage Flowable, Settable Bone Paste". The FDA issued a decision of Substantially Equivalent on March 13, 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.