FlareHawk Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

Integrity Implants Inc

The following data is part of a premarket notification filed by Integrity Implants Inc with the FDA for Flarehawk Interbody Fusion System.

Pre-market Notification Details

Device IDK182114
510k NumberK182114
Device Name:FlareHawk Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Integrity Implants Inc 850 Parkway Street Jupiter,  FL  33477
ContactLauren Kamer
CorrespondentLauren Kamer
Integrity Implants Inc 850 Parkway Street Jupiter,  FL  33477
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-06
Decision Date2019-01-07
Summary:summary

NIH GUDID Devices

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