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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K152237
Device Name The Entasis Dual-Lead Sacroiliac Implant
Applicant
Corelink, LLC
7606 Forsyth Blvd.
St.Louis,  MO  63105
Applicant Contact Dan Hoehn
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C Maxwell II
Regulation Number888.3040
Classification Product Code
OUR  
Date Received08/10/2015
Decision Date 02/04/2016
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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