510(k) K122623

SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT by Advanced Orthopaedic Solutions, Inc. — Product Code HRS

K122623 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. for the device "SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT". The FDA issued a decision of Substantially Equivalent on September 26, 2012. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Advanced Orthopaedic Solutions, Inc. has at least 10 other 510(k) clearances on record.