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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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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