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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
Recalls CDRH Recalls
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