Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda
BR Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Bone Cement-Normal Viscosity Ref K212729
FDA establishments
- Biomecanica Industria E Comercio De Produtos Ortopedicos Ltda Jau Sao Paulo · BR FEI 3009685086
What Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda makes
Biomecanica Industria E Comércio de Produtos Ortopédicos Ltda manufactures bone cement with normal viscosity, designed for orthopedic applications requiring standard setting properties during surgical procedures.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) pathway. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Biomecanica Industria E Comércio de Produtos Ortopédicos Ltda manufacture?
Biomecanica Industria E Comércio de Produtos Ortopédicos Ltda specializes in producing bone cement with normal viscosity. This product is specifically designed for orthopedic applications where standard setting properties are required during surgical procedures, such as joint replacements or fracture repairs.
Where is Biomecanica Industria E Comércio de Produtos Ortopédicos Ltda based?
The company is headquartered in the United States. This location influences its regulatory compliance framework, particularly for devices marketed within the U.S. market.
How are Biomecanica’s devices classified under U.S. regulations?
Biomecanica’s bone cement falls under the FDA’s Class II device classification. This classification is assigned based on the device’s intended use and associated risks, requiring special controls beyond general controls to ensure safety and effectiveness. Class II devices typically undergo a premarket notification (510(k)) process to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Biomecanica’s devices?
Biomecanica’s devices are listed via the FDA’s 510(k) pathway, meaning they have undergone the premarket notification process to demonstrate compliance with U.S. regulations. This pathway ensures the devices meet the necessary safety and performance standards before being marketed in the U.S. The company’s devices are documented in the FDA’s 510(k) database as part of this process.
Information
- Country
- BR