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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 K091870
Device Name TORNIER, PITON FIXATION IMPLANT SYSTEM
Applicant
Tornier
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Applicant Contact HOWARD L SCHRAYER
Correspondent
Tornier
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Correspondent Contact HOWARD L SCHRAYER
Regulation Number888.3040
Classification Product Code
MBI  
Date Received06/23/2009
Decision Date 09/21/2009
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
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