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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K111971
Device Name SYNDE-LOCK SYNDESMOSIS REPAIR KIT
Applicant
Tarsus Medical, Inc.
465 Fairchild Dr. Suite 230
Mountain View,  CA  94043
Applicant Contact NICHOLAS MOURLAS
Correspondent
Tarsus Medical, Inc.
465 Fairchild Dr. Suite 230
Mountain View,  CA  94043
Correspondent Contact NICHOLAS MOURLAS
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received07/11/2011
Decision Date 01/23/2012
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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