FDA 510(k) Applications for Medical Device Product Code "JDL"
(Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component))

FDA 510(k) Number Applicant Device Name Decision Date
K042841 BIOMET, INC. M2A/C2A ACETABULAR SYSTEM 12/21/2004
K051348 WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE TOTAL FEMORAL HEAD 08/19/2005
K061844 WRIGHT MEDICAL TECHNOLOGY, INC. DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER 12/06/2006
K070785 WRIGHT MEDICAL TECHNOLOGY, INC. DYNASTY ACETABULAR SYSTEM 07/11/2007
K004043 WRIGHT MEDICAL TECHNOLOGY, INC. METAL TRANSCEND ARTICULATION SYSTEM 07/13/2001
K051995 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR RENAISSANCE HIP STEM 08/22/2005
K041586 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR S HIP STEM 07/09/2004
K041114 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR TAPERED HIP STEM 05/28/2004
K073499 ZIMMER, INC. VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES 08/07/2008


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