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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K193491
Device Name restor3d Metallic Interference Screw
Applicant
Restor3D
311 W. Corporation St.
Durham,  NC  27701
Applicant Contact Nathan Evans
Correspondent
Restor3D
311 W. Corporation St.
Durham,  NC  27701
Correspondent Contact Nathan Evans
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/17/2019
Decision Date 03/19/2020
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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