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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 K083782
Device Name REGENEREX PATELLA COMPONENTS
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact SUSAN ALEXANDER
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact SUSAN ALEXANDER
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received12/19/2008
Decision Date 04/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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