Axis Orthopaedics
Country not established
- Devices
- 3
What Axis Orthopaedics makes
Axis Orthopaedics manufactures spinal fixation systems, including cervical and lumbar implants such as PEEK spacers, anterior cervical plates, and pedicle screws designed for surgical stabilization of the spine.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Axis Chena Cervical PEEK Spacer System Ref K181140
510(k) 510(k)Axis Anterior Cervical Plate System Ref K173867
510(k) 510(k)AXIS 5.5 Lumbar Pedicle Screw System Ref K180301
510(k) 510(k)
Frequently asked questions
How many devices does Axis Orthopaedics have in the registry?
The registry currently lists 3 devices for Axis Orthopaedics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Axis Orthopaedics's devices?
Among its 3 most recently registered devices, Axis Orthopaedics has devices listed in FDA 510(k) (3 devices).
What risk classes do Axis Orthopaedics's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Axis Orthopaedics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Axis Orthopaedics in the registry?
The most recently registered devices listed for Axis Orthopaedics include Axis Chena Cervical PEEK Spacer System, Axis Anterior Cervical Plate System and AXIS 5.5 Lumbar Pedicle Screw System.