Posterior Spine Truss System (PSTS) Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Lumbar

4Web, Inc.

The following data is part of a premarket notification filed by 4web, Inc. with the FDA for Posterior Spine Truss System (psts) Interbody Fusion Device.

Pre-market Notification Details

Device IDK171351
510k NumberK171351
Device Name:Posterior Spine Truss System (PSTS) Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant 4Web, Inc. 6170 REsearch Rd., Suite 219 Frisco,  TX  75033
ContactJessee Hunt
CorrespondentRich Jansen
Silver Pine Consulting, LLC. 3851 Mossy Oak Drive Ft. Myers,  FL  33905
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-09
Decision Date2017-09-08
Summary:summary

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