Ortobio S.A.
BrazilFDA applicant, unverified
- Devices
- 1
What Ortobio S.A. makes
Ortobio S.A. manufactures orthopedic anchors designed for surgical fixation, including models with fiber wire and disposable inserters for bone attachment procedures.
These devices are classified as Class II under Brazilian regulations and have been submitted for 510(k) clearance via the FDA pathway. The company is based in Brazil.
Catalogue
Anchor with Fiber Wire and Disposable Inserter Ref K253027
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ortobio S.A. have in the registry?
The registry currently lists 1 device for Ortobio S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortobio S.A.'s devices?
Among its 1 most recently registered device, Ortobio S.A. has devices listed in FDA 510(k) (1 device).
What risk classes do Ortobio S.A.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ortobio S.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ortobio S.A. in the registry?
The most recently registered devices listed for Ortobio S.A. include Anchor with Fiber Wire and Disposable Inserter.