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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K172294
Device Name Osteotomy Truss System (OTS)
Applicant
4Web, Inc.
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Applicant Contact Jessee Hunt
Correspondent
Silver Pine Consulting, LLC
1142 26 1/2 Ave.
Cumberland,  WI  54829
Correspondent Contact Rich Jansen
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/31/2017
Decision Date 02/22/2018
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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