Spineworxx AG
SwitzerlandFDA applicant, unverified
- Devices
- 1
What Spineworxx AG makes
Spineworxx AG manufactures interbody fusion cages, including the Born PT-LIF Cage HA, designed for spinal stabilization procedures in the lumbar region. These devices are intended for use in posterior lumbar interbody fusion (PLIF) surgeries to support spinal segment integrity and promote bone fusion.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the U.S. market. The company is headquartered in the United States.
Catalogue
Born PT-LIF Cage HA Ref K202380
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spineworxx AG have in the registry?
The registry currently lists 1 device for Spineworxx AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spineworxx AG's devices?
Among its 1 most recently registered device, Spineworxx AG has devices listed in FDA 510(k) (1 device).
What risk classes do Spineworxx AG's devices fall under?
Among its 1 most recently registered device, the classes recorded for Spineworxx AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spineworxx AG in the registry?
The most recently registered devices listed for Spineworxx AG include Born PT-LIF Cage HA.