Cervical Spinal Truss System (CSTS) Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Cervical

4Web, Inc.

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

Pre-market Notification Details

Device IDK173159
510k NumberK173159
Device Name:Cervical Spinal Truss System (CSTS) Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant 4Web, Inc. 2801 Network Blvd.,Suite 620 Frisco,  TX  75034
ContactJessee Hunt
CorrespondentRich Jansen
Silver Pine Consulting 11821 Bramble Cove Drive Ft. Myers,  FL  33905
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-01-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812998033607 K173159 000
00812998033591 K173159 000
00812998033584 K173159 000
00812998033577 K173159 000

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