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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K173159
Device Name Cervical Spinal Truss System (CSTS) Interbody Fusion Device
Applicant
4Web, Inc.
2801 Network Blvd.,Suite 620
Frisco,  TX  75034
Applicant Contact Jessee Hunt
Correspondent
Silver Pine Consulting
11821 Bramble Cove Drive
Ft. Myers,  FL  33905
Correspondent Contact Rich Jansen
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/29/2017
Decision Date 01/08/2018
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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