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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 K212729
Device Name Bone Cement-Normal Viscosity
Applicant
Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda
Rua Luiz Pengo 145
Jau,  BR 17212-811
Applicant Contact Thais Busquim
Correspondent
Passarini Regulatory Affairs/ PR Servicos
Regulatorios Administrativos Ltda Me
Rua Alice Alem Saadi, 855/2402
Ribeirao Preto,  BR 14096-570
Correspondent Contact Graziela Brum
Regulation Number888.3027
Classification Product Code
LOD  
Date Received08/27/2021
Decision Date 05/31/2022
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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