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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K083070
Device Name TOGGLELOC SYSTEM
Applicant
Biomet Sports Medicine
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact ROBERT FRIDDLE
Correspondent
Biomet Sports Medicine
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact ROBERT FRIDDLE
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
JDR  
Date Received10/15/2008
Decision Date 12/16/2008
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
Recalls CDRH Recalls
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