Kalitec Direct LLC
Country not established
- Devices
- 3,532
What Kalitec Direct LLC makes
Kalitec Direct LLC manufactures spinal fixation devices, including non-bioabsorbable pedicle screws, metallic and polymeric interbody fusion cages for lumbar and cervical applications, and reusable bone preparation tools such as manual bone files, taps, and internal fixation rods and connectors. Their portfolio also includes minimally invasive spinal fixation systems and specialized instruments for spinal surgery, such as the InTess and TiWAVE cage systems.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates in the United States, adhering to applicable regulatory requirements for spinal implants and surgical instruments.
Catalogue
Search and filter all 3,532 devicesShowing 1-50 of 3,532
Company details
- DUNS number
- 041956211
Frequently asked questions
How many devices does Kalitec Direct LLC have in the registry?
The registry currently lists 3532 devices for Kalitec Direct LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kalitec Direct LLC's devices?
Among its 50 most recently registered devices, Kalitec Direct LLC has devices listed in FDA GUDID (50 devices).
What risk classes do Kalitec Direct LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Kalitec Direct LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kalitec Direct LLC in the registry?
The most recently registered devices listed for Kalitec Direct LLC include Kalitec Universal Instruments 01-K06-2000, InTess Lumbar Cage 12-K01-0212, CosmoLock Pedicle Screw System 10-SNT-5565 and Cosmolock 11-RSC-0050.