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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K211789
Device Name restor3d Pin Implants
Applicant
Restor3D
311 W. Corporation St.
Durham,  NC  27701
Applicant Contact Lexi Lewis
Correspondent
Restor3D
311 W. Corporation St.
Durham,  NC  27701
Correspondent Contact Lexi Lewis
Regulation Number888.3040
Classification Product Code
HTY  
Date Received06/10/2021
Decision Date 01/04/2022
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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