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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 K220523
Device Name restor3d TiDAL Lumbar Interbody Fusion Device
Applicant
Restor3D
404 Hunt St.
Suite 500
Durham,  NC  27701
Applicant Contact Shyam Patel
Correspondent
Restor3D
404 Hunt St.
Suite 500
Durham,  NC  27701
Correspondent Contact Shyam Patel
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/23/2022
Decision Date 06/17/2022
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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