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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K172620
Device Name SyndesMetrics Syndesmosis Repair System
Applicant
Mortise Medical, LLC
124 S. 600 W.
Suite 100
Logan,  UT  84321
Applicant Contact Robert Hoy
Correspondent
Mortise Medical, LLC
124 S. 600 W.
Suite 100
Logan,  UT  84321
Correspondent Contact Robert Hoy
Regulation Number888.3030
Classification Product Code
HTN  
Date Received08/31/2017
Decision Date 11/08/2017
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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