Ortosíntese Indústria e Comércio Ltda.
Orthopedic implants and instruments
Brazilian manufacturer of orthopedic implants, plates, screws, and surgical instruments for trauma and spine. Ortosíntese supplies hospitals throughout Latin America with CE-marked and ANVISA-approved products.
- Type
- Manufacturer
- Location
- São Paulo, Brazil
- Founded
- 1975
- Website
- https://www.ortosintese.com.br
- Categories
- Medical & Healthcare Supplies
- Markets
- Brazil, Argentina, Chile, Colombia
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-14 Mail server of the company domain
- domain-registered (green), checked 2026-08-14 Domain registry record
- debarment-clear (green), checked 2026-08-14 OpenSanctions
- sanctions-clear (green), checked 2026-08-14 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- FDA Registered FDA Establishment Registration
- Good Manufacturing Practice
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)