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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 uncemented acetabular component)
510(k) Number K113271
Device Name METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
Original Applicant
BIOMET MANUFACTURING, INC.
56 east bell dr.
p.o box 587
warsaw,  IN  46581 0587
Original Contact gary baker
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Code
LPH  
Date Received11/04/2011
Decision Date 05/18/2012
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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