Orthonovis, Inc.
United StatesFDA applicant, unverified FDA FEI 3015946784
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Orthonovis, Inc. makes
Orthonovis, Inc. manufactures orthopedic fixation systems, including external fixation devices like the ONX Large External Fixation System, as well as internal fixation solutions such as the BPS Wrist Fracture System, cannulated screws, Kirschner wires, and bone fragment fixation plates, screws, and washers.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
ONX Large External Fixation System Ref K213905
Regimes: 510(k) Registry: 510(k)BPS Wrist Fracture System Ref K250498
Regimes: 510(k) Registry: 510(k)BPS Wrist Fracture System Ref K242343
Regimes: 510(k) Registry: 510(k)Cannulated Screw and Kirschner (K wire) System Ref K252758
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3015946784
- Address
- 1 Hargrove Grade Ste 4, Palm Coast, FL, 32137
Frequently asked questions
How many devices does Orthonovis, Inc. have in the registry?
The registry currently lists 5 devices for Orthonovis, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthonovis, Inc.'s devices?
Among its 5 most recently registered devices, Orthonovis, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Orthonovis, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Orthonovis, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthonovis, Inc. in the registry?
The most recently registered devices listed for Orthonovis, Inc. include ONX Large External Fixation System, BPS Wrist Fracture System, Cannulated Screw and Kirschner (K wire) System and BPS - Bone Fragment Fixation Plates, Screws and Washers.