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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/Femoral, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K123907
Device Name PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact ELIZABETH WRAY
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact ELIZABETH WRAY
Regulation Number888.3540
Classification Product Code
KRR  
Date Received12/19/2012
Decision Date 09/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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