FDA 510(k) Applications for Medical Device Product Code "MAY"
(Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish)

FDA 510(k) Number Applicant Device Name Decision Date
K090103 BIOMET, INC. 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL 02/11/2009
K123604 HOWMEDICA OSTEONICS CORP ABG III MONOLITHIC HIP STEM 08/16/2013
K051844 PORTLAND ORTHOPAEDICS PTY. LTD. EQUATOR PLUS ACETABULAR CUP SYSTEM 10/07/2005
K110807 STRYKER CORP. ABG II MONOLITHIC HIP STEM 05/25/2011


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