510(k) K983885

BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES by Howmedica, Inc. — Product Code JEY

K983885 is an FDA 510(k) premarket notification submitted by Howmedica, Inc. for the device "BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES". The FDA issued a decision of Substantially Equivalent on January 29, 1999. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Howmedica, Inc. has at least 10 other 510(k) clearances on record.