510(k) K241027

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

K241027 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "Permatage Settable Bone Putty". The FDA issued a decision of Substantially Equivalent on September 26, 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.