510(k) K071791

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 by Codman & Shurtleff, Inc. — Product Code GXP

K071791 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280". The FDA issued a decision of Substantially Equivalent on July 30, 2007. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.