Lumbar Spine Truss System Plating Solution (LSTS-PS)

Appliance, Fixation, Spinal Intervertebral Body

4Web, Inc.

The following data is part of a premarket notification filed by 4web, Inc. with the FDA for Lumbar Spine Truss System Plating Solution (lsts-ps).

Pre-market Notification Details

Device IDK203065
510k NumberK203065
Device Name:Lumbar Spine Truss System Plating Solution (LSTS-PS)
ClassificationAppliance, Fixation, Spinal Intervertebral Body
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 CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-09
Decision Date2021-03-10

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