510(k) K181587

ORTHOLOC SPS Shoulder Plating System by Tornier, Inc. — Product Code HRS

K181587 is an FDA 510(k) premarket notification submitted by Tornier, Inc. for the device "ORTHOLOC SPS Shoulder Plating System". The FDA issued a decision of Substantially Equivalent on October 5, 2018. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Tornier, Inc. has at least 10 other 510(k) clearances on record.