EVOL Spinal Interbody System

Intervertebral Fusion Device With Bone Graft, Lumbar

Cutting Edge Spine, LLC

The following data is part of a premarket notification filed by Cutting Edge Spine, Llc with the FDA for Evol Spinal Interbody System.

Pre-market Notification Details

Device IDK200991
510k NumberK200991
Device Name:EVOL Spinal Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Cutting Edge Spine, LLC 101 Waxhaw Professional Park, Suite A Waxhaw,  NC  28173
ContactKyle Kuntz
CorrespondentKyle Kuntz
Cutting Edge Spine, LLC 101 Waxhaw Professional Park, Suite A Waxhaw,  NC  28173
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-15
Decision Date2020-05-13

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