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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K201900
Device Name 3D GraftRasp System
Applicant
Surgentec
911 Clint Moore Rd.
Boca Raton,  FL  33847
Applicant Contact Andrew Shoup
Correspondent
Surgentec
911 Clint Moore Rd.
Boca Raton,  FL  33847
Correspondent Contact Andrew Shoup
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
HTR  
Date Received07/08/2020
Decision Date 09/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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