510(k) K032072

LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE by Arthrotek, Inc. — Product Code HWC

K032072 is an FDA 510(k) premarket notification submitted by Arthrotek, Inc. for the device "LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE". The FDA issued a decision of Substantially Equivalent on October 1, 2003. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Arthrotek, Inc. has at least 10 other 510(k) clearances on record.