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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 integrated fixation, cervical
510(k) Number K190870
Device Name Cervical Spinal Truss System-Stand Alone (CSTS-SA)
Applicant
4Web, Inc.
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Applicant Contact Jessee Hunt
Correspondent
Silver Pine Consulting, LLC.
3851 Mossy Oak Drive
Ft. Myers,  FL  33905
Correspondent Contact Rich Jansen
Regulation Number888.3080
Classification Product Code
OVE  
Date Received04/03/2019
Decision Date 08/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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