Cleared Traditional

Bone Cement-Normal Viscosity

K212729 · Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda · Orthopedic

May 2022

Decision

277d

Days

Class 2

Risk

About This 510(k) Submission

K212729 is an FDA 510(k) clearance for the Bone Cement-Normal Viscosity, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda (Jau, BR). The FDA issued a Cleared decision on May 31, 2022, 277 days after receiving the submission on August 27, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K212729 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2021
Decision Date	May 31, 2022
Days to Decision	277 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF