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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, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K080330
FOIA Releasable 510(k) K080330
Device Name SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
Applicant
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581
Applicant Contact PATRICIA S BERES
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581
Correspondent Contact PATRICIA S BERES
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Code
JDI  
Date Received02/06/2008
Decision Date 06/11/2008
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
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