Xelite Biomed, Ltd.
TaiwanFDA applicant, unverified
- Devices
- 3
What Xelite Biomed, Ltd. makes
Xelite Biomed, Ltd. manufactures spinal bone cement systems, including high-viscosity formulations like the VertehighFix and SuperM-Fix, designed for vertebral augmentation procedures.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
XeliteMed SuperM-Fix Spinal Bone Cement Ref K251896
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Xelite Biomed, Ltd. have in the registry?
The registry currently lists 3 devices for Xelite Biomed, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xelite Biomed, Ltd.'s devices?
Among its 3 most recently registered devices, Xelite Biomed, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Xelite Biomed, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Xelite Biomed, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xelite Biomed, Ltd. in the registry?
The most recently registered devices listed for Xelite Biomed, Ltd. include XeliteMed VertehighFix High Viscosity Spinal Bone Cement System, XeliteMed VertehighFix High Viscosity Spinal Bone Cement and XeliteMed SuperM-Fix Spinal Bone Cement.