510(k) K040112

TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE by Tri-Med, Inc. — Product Code HRS

K040112 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE". The FDA issued a decision of Substantially Equivalent on March 12, 2004. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Tri-Med, Inc. has at least 10 other 510(k) clearances on record.