Cervical Spinal Truss System-Stand Alone (CSTS-SA)

Intervertebral Fusion Device With Integrated Fixation, Cervical

4Web, Inc.

The following data is part of a premarket notification filed by 4web, Inc. with the FDA for Cervical Spinal Truss System-stand Alone (csts-sa).

Pre-market Notification Details

Device IDK190870
510k NumberK190870
Device Name:Cervical Spinal Truss System-Stand Alone (CSTS-SA)
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant 4Web, Inc. 2801 Network Blvd. Suite 620 Frisco,  TX  75034
ContactJessee Hunt
CorrespondentRich Jansen
Silver Pine Consulting, LLC. 3851 Mossy Oak Drive Ft. Myers,  FL  33905
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-03
Decision Date2019-08-12

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