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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K183184
Device Name FlareHawk Interbody Fusion System
Applicant
Integrity Implants Inc
850 Parkway Street
Jupiter,  FL  33477
Applicant Contact Lauren Kamer
Correspondent
Integrity Implants Inc
850 Parkway Street
Jupiter,  FL  33477
Correspondent Contact Lauren Kamer
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/19/2018
Decision Date 04/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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