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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 K093235
Device Name RINGLOC + HYBRID ACETABULAR SYSTEM
Applicant
BIOMET, INC.
56 east bell dr.
warsaw,  IN  46581 0587
Contact gary baker
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
LPH   LZO  
Date Received10/15/2009
Decision Date 04/30/2010
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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