Kalitec Medical
Country not established
- Devices
- 3
What Kalitec Medical makes
Kalitec Medical manufactures the NIDO Pedicle Screw System, a spinal fixation device used for internal orthopedic stabilization in surgical procedures.
The NIDO Pedicle Screw System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Navagio Lumbar Cage Ref K220902
Regimes: 510(k) Registry: 510(k)TiWAVE-L Porous Titanium Lumbar Cage Ref K182210
Regimes: 510(k) Registry: 510(k)NIDO™ Pedicle Screw System Ref K230974
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kalitec Medical have in the registry?
The registry currently lists 3 devices for Kalitec Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kalitec Medical's devices?
Among its 3 most recently registered devices, Kalitec Medical has devices listed in FDA 510(k) (3 devices).
What risk classes do Kalitec Medical's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Kalitec Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kalitec Medical in the registry?
The most recently registered devices listed for Kalitec Medical include Navagio Lumbar Cage, TiWAVE-L Porous Titanium Lumbar Cage and NIDO™ Pedicle Screw System.