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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K211163
Device Name Bone Cement Genta, Bone Cement HV, Bone Cement LV
Applicant
Tecres S.P.A.
Via Andrea Doria 6
Sommacampagna,  IT 37066
Applicant Contact Massimo Grazioli
Correspondent
Brauer Device Consultant, LLC
7 Trl. House Ct.
Rockville,  MD  20850
Correspondent Contact Christine Brauer
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received04/19/2021
Decision Date 01/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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