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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 K033838
Device Name TITANIUM TOGGLE BUTTON(S)
Applicant
Biomet Manufacturing, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact TRACY J BICKEL
Correspondent
Biomet Manufacturing, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact TRACY J BICKEL
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/10/2003
Decision Date 02/13/2004
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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