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 IDK202198
510k NumberK202198
Device Name:FlareHawk 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 Received2020-08-05
Decision Date2020-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810045530949 K202198 000
00810045530444 K202198 000
00810045530437 K202198 000
00810045530420 K202198 000
00810004729964 K202198 000
00810004729957 K202198 000
00810004729940 K202198 000
00810004729933 K202198 000
00810004729926 K202198 000
00810004729919 K202198 000
00818613021400 K202198 000
00818613021394 K202198 000
00818613021387 K202198 000
00818613021370 K202198 000
00818613021363 K202198 000
00810045530451 K202198 000
00810045530468 K202198 000
00810045530932 K202198 000
00810045530925 K202198 000
00810045530918 K202198 000
00810045530901 K202198 000
00810045530895 K202198 000
00810045530550 K202198 000
00810045530543 K202198 000
00810045530536 K202198 000
00810045530529 K202198 000
00810045530512 K202198 000
00810045530505 K202198 000
00810045530499 K202198 000
00810045530482 K202198 000
00810045530475 K202198 000
00818613021356 K202198 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.