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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 K234087
Device Name restor3d TIDAL Lumbar Interbody Fusion System
Applicant
Restor3d
4001 E. Nc 54 Highway, Suite 3160
Durham,  NC  27709
Applicant Contact Anika Moorjani
Correspondent
Restor3d
4001 E. Nc 54 Highway, Suite 3160
Durham,  NC  27709
Correspondent Contact Anika Moorjani
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/22/2023
Decision Date 01/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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