b47ee12a-5247-441a-a445-29c61f1f9d67UpdatePublished22024-01-082019-05-24In Commercial Distribution08033390140065PrimaryGS1TEMA Elbow1550.15.0111550.15.011432066322LIMACORPORATE SPA1Humeral Body small right falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse33702Uncoated elbow humerus prosthesisA sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.trueActiveJDCProsthesis, Elbow, Constrained, CementedJDBProsthesis, Elbow, Semi-Constrained, CementedDevice Size Text, specifysmall righttruefalse