PATHWAY AVID

Intervertebral Fusion Device With Bone Graft, Lumbar

CUSTOM SPINE, INC.

The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Pathway Avid.

Pre-market Notification Details

Device IDK090566
510k NumberK090566
Device Name:PATHWAY AVID
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany,  NJ  07054
ContactSaad Attiyah
CorrespondentSaad Attiyah
CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany,  NJ  07054
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-03
Decision Date2009-06-01
Summary:summary

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