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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
510(k) Number K121297
Device Name ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
Original Applicant
SIGNATURE ORTHOPAEDICS, PTY, LTD
125 greville st
chatswood,  AU 2067
Original Contact declan brazil
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
MEH  
Date Received04/30/2012
Decision Date 12/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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