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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 K052685
Device Name ORTHOPEDIC SALVAGE SYSTEM- OSS
Applicant
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Applicant Contact ALLISON KOSKEY
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact ALLISON KOSKEY
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Code
JDI  
Date Received09/28/2005
Decision Date 10/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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