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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K053505
Device Name REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS
Applicant
BIOMET MANUFACTURING, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Applicant Contact TRACY B JOHNSON
Correspondent
BIOMET MANUFACTURING, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Correspondent Contact TRACY B JOHNSON
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   KRO  
Date Received12/16/2005
Decision Date 08/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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