Orthofix Medical, Inc.
Country not established
- Devices
- 1
What Orthofix Medical, Inc. makes
Orthofix Medical, Inc. manufactures spinal interbody fusion systems, including expandable and fixed-height devices for anterior cervical, thoracic, and lumbar applications. Their portfolio includes modular constructs like the Reef TO/TA and Regatta Lateral systems, as well as modular interbody cages such as the WaveForm series and Shoreline ACS/RT systems. Additional offerings include the FORZA XP expandable spacer and the Meridian interbody system, designed for various surgical approaches.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The company’s products are registered with the FDA under the 510(k) clearance process. Orthofix Medical, Inc. is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orthofix Medical, Inc. have in the registry?
The registry currently lists 1 device for Orthofix Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthofix Medical, Inc.'s devices?
Among its 1 most recently registered device, Orthofix Medical, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Orthofix Medical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Orthofix Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthofix Medical, Inc. in the registry?
The most recently registered devices listed for Orthofix Medical, Inc. include Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System.