510(k) K212729

Bone Cement-Normal Viscosity by Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda — Product Code LOD

K212729 is an FDA 510(k) premarket notification submitted by Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda for the device "Bone Cement-Normal Viscosity". The FDA issued a decision of Substantially Equivalent on May 31, 2022. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027.