510(k) K040594

HERCULON SOFT TISSUE REATTACHMENT SYSTEM by United States Surgical, A Division of Tyco Healthc — Product Code HWC

K040594 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "HERCULON SOFT TISSUE REATTACHMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 31, 2004. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.