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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 K191516
Device Name Ali Interbody Fusion System
Applicant
Raed M. Ali, M.D., Inc.
6 Starcatcher
Newport Coast,  CA  92657
Applicant Contact Raed Ali
Correspondent
Trans1
3804 Park Ave.
Wilmington,  NC  28403
Correspondent Contact Kristen Allen
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/07/2019
Decision Date 09/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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