Qualgenix
Country not established
- Devices
- 4
What Qualgenix makes
Qualgenix manufactures spinal fixation devices, including the Ayers Rock Cervical Cage for cervical spine stabilization and the Mont Blanc Pedicle Screw Systems for internal fixation in spinal surgeries.
These products are classified as Class II devices under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
Twin Peaks Lumbar Cage Ref K112696
Regimes: 510(k) Registry: 510(k)Ayers Rock Cervical Cage Ref K112801
Regimes: 510(k) Registry: 510(k)Blue Mountain Cervical Plate Ref K112809
Regimes: 510(k) Registry: 510(k)Mont Blanc Pedicle Screw Systems Ref K112684
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Qualgenix have in the registry?
The registry currently lists 4 devices for Qualgenix. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qualgenix's devices?
Among its 4 most recently registered devices, Qualgenix has devices listed in FDA 510(k) (4 devices).
What risk classes do Qualgenix's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Qualgenix's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Qualgenix in the registry?
The most recently registered devices listed for Qualgenix include TWIN PEAKS LUMBAR CAGE, AYERS ROCK CERVICAL CAGE, BLUE MOUNTAIN CERVICAL PLATE and MONT BLANC PEDICLE SCREW SYSTEMS.