510(k) K853066

MAYFIELD DISPOSABLE SKULL PINS by Codman & Shurtleff, Inc. — Product Code HAX

K853066 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "MAYFIELD DISPOSABLE SKULL PINS". The FDA issued a decision of Substantially Equivalent on August 8, 1985. The device falls under product code HAX (Tong, Skull For Traction), a Class II device regulated under 21 CFR 882.5960. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.