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