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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 K062998
Device Name COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
Applicant
BIOMET MANUFACTURING CORP.
po box 587
warsaw,  IN  46581 0587
Contact jing xie
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KRO   KWY   KWZ  
LPH   LZO   MEH  
Date Received10/02/2006
Decision Date 01/19/2007
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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