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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Hemi-, Phalangeal
510(k) Number K201393
Device Name restor3d MTP Implant
Applicant
Restor3D, Inc.
311 W. Corporation St.
Durham,  NC  27701
Applicant Contact Nathan Evans
Correspondent
Restor3D, Inc.
311 W. Corporation St.
Durham,  NC  27701
Correspondent Contact Jillian Udell
Regulation Number888.3730
Classification Product Code
KWD  
Date Received05/27/2020
Decision Date 05/25/2022
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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