4WEB SPINAL IMPLANT PRODUCTS

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 4web Spinal Implant Products.

Pre-market Notification Details

Device IDK142112
510k NumberK142112
Device Name:4WEB SPINAL IMPLANT PRODUCTS
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant 4WEB, INC. 11821 BRAMBLE COVE DRIVE Ft.myers,  FL  33905
ContactRich Jansen
CorrespondentRich Jansen
4WEB, INC. 11821 BRAMBLE COVE DRIVE Ft.myers,  FL  33905
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-04
Decision Date2014-09-23
Summary:summary

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