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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K212527
Device Name Cervical Spine Truss System Plating Solution (CSTS-PS)
Applicant
4Web Medical, Inc.
2801 Network Blvd.
Suite 620
Frisco,  TX  75034
Applicant Contact Lewis Harrison
Correspondent
Silver Pine Consulting
3851 Mossy Oak Dr.
Fort Myers,  FL  33905
Correspondent Contact Richard Jansen
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/11/2021
Decision Date 05/17/2022
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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