Data / Medical devices / Brazil / Biomecanica Industria E Comercio De Produtos Ortopedicos Ltda
Biomecanica Industria E Comercio De Produtos Ortopedicos Ltda: FDA-registered device maker in Jau Sao Paulo, Brazil, 1 510(k) clearance
Biomecanica Industria E Comercio De Produtos Ortopedicos Ltda is registered with the FDA (registration 3009685086) in Jau Sao Paulo, Brazil. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 31, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009685086
- Address
- Rua Luiz Pengo 145, Jau Sao Paulo, Brazil, 17212811
- Owner or operator
- Biomecanica Industria e Comercio de Produtos Ortopedicos Ltd (10093117)
- Roles
- Manufacturer
- First device listed
- April 1, 2025
- Registered through
- 2026
- Brand names listed
- Bone Cement - Normal Viscosity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Cement | LOD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 31, 2022 | K212729 | Bone Cement-Normal Viscosity | LOD | Substantially Equivalent | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | accessdata.fda.gov |
Compare with other makers
Updated May 31, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.