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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 K021260
Device Name REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
Applicant
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Applicant Contact SARA B SHULTZ
Correspondent
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Correspondent Contact SARA B SHULTZ
Regulation Number888.3510
Classification Product Code
KRO  
Date Received04/19/2002
Decision Date 06/05/2002
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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