FDA 510(k) Applications for Medical Device Product Code "MJT"
(Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented)

FDA 510(k) Number Applicant Device Name Decision Date
K960363 BIOMET, INC. BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 02/18/1997
K982418 ENDOTEC, INC. BUECHEL-PAPPAS MODULAR SALVAGE STEM 04/29/1999
K990712 HOWMEDICA OSTEONICS CORP. OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM 07/20/1999


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