Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda
BrazilFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
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.
Catalogue
Bone Cement-Normal Viscosity Ref K212729
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Biomecanica Industria E Comercio De Produtos Ortopedicos Ltda Jau Sao Paulo · BR FEI 3009685086
Frequently asked questions
How many devices does Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda have in the registry?
The registry currently lists 1 device for Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda's devices?
Among its 1 most recently registered device, Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda has devices listed in FDA 510(k) (1 device).
What risk classes do Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda's devices fall under?
Among its 1 most recently registered device, the classes recorded for Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda in the registry?
The most recently registered devices listed for Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda include Bone Cement-Normal Viscosity.
Which FDA establishments are linked to Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda?
1 FDA establishment is linked to Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda in the registry; they are listed on the company page.