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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, constrained, cemented or uncemented, metal/polymer, + additive
510(k) Number K121874
Device Name G7 ACETABULAR SYSTEM
Original Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw,  IN  46581 0587
Original Contact becky earl
Regulation Number888.3310
Classification Product Code
PBI  
Subsequent Product Codes
JDI   KWZ   LPH   LZO   OQG  
OQH   OQI  
Date Received06/27/2012
Decision Date 11/23/2012
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
Recalls CDRH Recalls
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