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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 K130033
Device Name TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact ELIZABETH WRAY
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact ELIZABETH WRAY
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
JDR  
Date Received01/04/2013
Decision Date 08/01/2013
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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