FlareHawk TiHawk9 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 Tihawk9 Interbody Fusion System.

Pre-market Notification Details

Device IDK201367
510k NumberK201367
Device Name:FlareHawk TiHawk9 Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens,  FL  33418
ContactLauren Kamer
CorrespondentLauren Kamer
Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens,  FL  33418
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-22
Decision Date2020-09-23

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