Bone Cement-Normal Viscosity

FDA 510(k) K212729 · Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda

Substantially Equivalent

510(k) numberK212729

Submission

Device name
Bone Cement-Normal Viscosity
Applicant
Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda
Jau, BR
Received
August 27, 2021
Decision date
May 31, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LOD – Bone Cement
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3027
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code LOD

510(k)DeviceApplicantDecision
K254107Refobacin Bone Cement R (110034355)LOD · Traditional Biomet France04/15/2026SE
K250760SPECTRUM GV Bone CementLOD · Special Osteoremedies, LLC04/02/2025SE
K241674Osteopal® VLOD · Traditional Heraeus Medical GmbH12/05/2024SE
K231556SPECTRUM® GV Bone CementLOD · Traditional Osteoremedies, LLC12/20/2023SE
K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVLOD · Traditional Tecres S.P.A.01/09/2023SE
K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…LOD · Traditional Ormed Grup Medikal Turizm Saglik Hizmetleri…05/19/2022SE
K213812PALACOS MV proLOD · Traditional Heraeus Medical GmbH02/02/2022SE
K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD · Traditional Heraeus Medical GmbH07/09/2021SE
K202458BonOs Inject, Pedicle screw kits, Cement pusherLOD · Traditional Osartis GmbH05/18/2021SE
K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaLOD · Traditional Osartis GmbH03/19/2021SE

Questions and answers

When was Bone Cement-Normal Viscosity cleared by the FDA?

Bone Cement-Normal Viscosity (K212729) received a 510(k) decision of Substantially Equivalent on May 31, 2022, 277 days after the submission was received.

What is the product code of K212729?

The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.