FDA 510(k) Application Details - K212729

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K212729
Device Name	Bone Cement
Applicant	Biomecanica Industria e Comerciode Produtos Ortopedicos LTDA Rua Luiz Pengo 145 Jau 17212-811 BR Other 510(k) Applications for this Company
Contact	Thais Busquim Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	LOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2021
Decision Date	05/31/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review