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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