510(k) K914804

RADIUS OSTEOTOMY PLATES by Link America, Inc. — Product Code HRS

K914804 is an FDA 510(k) premarket notification submitted by Link America, Inc. for the device "RADIUS OSTEOTOMY PLATES". The FDA issued a decision of SN on April 29, 1992. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Link America, Inc. has at least 10 other 510(k) clearances on record.