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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 K121034
Device Name IOI TOTAL HIP
Applicant
ICONACY ORTHOPEDIC IMPLANTS, LLC
po box 1033
warsaw,  IN  46581 1033
Contact roy y hori, phd
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LWJ  
Date Received04/05/2012
Decision Date 09/04/2012
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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