510(k) K171831

Intra-Lock Bone Fixation System by Intra-Lock International, Inc. — Product Code DZL

K171831 is an FDA 510(k) premarket notification submitted by Intra-Lock International, Inc. for the device "Intra-Lock Bone Fixation System". The FDA issued a decision of Substantially Equivalent on October 26, 2017. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Intra-Lock International, Inc. has at least 10 other 510(k) clearances on record.