STAXX IBL SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

SPINE WAVE, INC.

The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Staxx Ibl System.

Pre-market Notification Details

Device IDK132719
510k NumberK132719
Device Name:STAXX IBL SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SPINE WAVE, INC. 3 ENTERPRISE DR. SUITE 210 Shelton,  CT  06484
ContactRoaida Rizkallah
CorrespondentRoaida Rizkallah
SPINE WAVE, INC. 3 ENTERPRISE DR. SUITE 210 Shelton,  CT  06484
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-30
Decision Date2013-10-04
Summary:summary

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