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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Wedge
510(k) Number K191047
Device Name ADI TiDAL Osteotomy Wedge
Applicant
Additive Device, Inc. (Adi) D/B/A Restor3D
311 W. Corporation St.
Durham,  NC  27701
Applicant Contact Nathan Evans
Correspondent
Additive Device, Inc. (Adi) D/B/A Restor3D
311 W. Corporation St.
Durham,  NC  27701
Correspondent Contact Nathan Evans
Regulation Number888.3030
Classification Product Code
PLF  
Date Received04/19/2019
Decision Date 11/05/2019
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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