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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 K073637
Device Name PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
Original Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw,  IN  46581 0587
Original Contact elizabeth wray
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   KWY   KWZ   LPH  
Date Received12/26/2007
Decision Date 03/20/2008
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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