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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 K071569
Device Name ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
Applicant
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581
Applicant Contact ELIZABETH WRAY
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581
Correspondent Contact ELIZABETH WRAY
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Codes
FZP   NEU  
Date Received06/08/2007
Decision Date 07/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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