Sofamor Danek
Country not established
- Devices
- 2
What Sofamor Danek makes
Sofamor Danek manufactures spinal fixation and fusion devices, including modifications to the ZPlate-ATL anterior fixation system and the Novus™ LC interbody fusion device. These products are designed for surgical applications in spinal stabilization and intervertebral support.
The company’s portfolio is regulated under FDA Class II devices, with authorisations recorded via 510(k) and PMA pathways. The devices are listed in the FDA registry, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Novus (Tm) Lc Interbody Fusion Device Ref P970015
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Sofamor Danek have in the registry?
The registry currently lists 2 devices for Sofamor Danek. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sofamor Danek's devices?
Among its 2 most recently registered devices, Sofamor Danek has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sofamor Danek's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sofamor Danek's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sofamor Danek in the registry?
The most recently registered devices listed for Sofamor Danek include MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM and NOVUS (TM) LC INTERBODY FUSION DEVICE.