4-WEB ALIF SPINAL TRUSS SYSTEM (STS)

Intervertebral Fusion Device With Bone Graft, Lumbar

4-WEB, INC.

The following data is part of a premarket notification filed by 4-web, Inc. with the FDA for 4-web Alif Spinal Truss System (sts).

Pre-market Notification Details

Device IDK112316
510k NumberK112316
Device Name:4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant 4-WEB, INC. 13540 GUILD AVE. Apple Valley,  MN  55124
ContactRich Jansen, Pharm. D.
CorrespondentRich Jansen, Pharm. D.
4-WEB, INC. 13540 GUILD AVE. Apple Valley,  MN  55124
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-11
Decision Date2011-12-14
Summary:summary

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