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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 K171964
Device Name LigaMetrics Suture Anchors
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 Number888.3040
Classification Product Code
MBI  
Date Received06/30/2017
Decision Date 09/19/2017
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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