Clearance Summary
Bone Cement-Normal Viscosity received FDA 510(k) clearance under submission number K212729, sponsored by Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-05-31.
- Submission: K212729
- Applicant / Sponsor: Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2022-05-31
Classification & Regulation
This clearance is catalogued under FDA product code LOD and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.