K2m, Incorporated
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What K2m, Incorporated makes
K2m, Incorporated manufactures spinal fixation devices, including non-bioabsorbable bone screws and interbody systems for internal orthopaedic stabilization. Their portfolio includes modular spinal systems for cervical, thoracic, and lumbar applications, as well as miniaturized and expandable designs for targeted spinal support.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) premarket notifications and the Unique Device Identifier (UDI) system. The company’s products are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Catalogue
RANGE/DENALI/MESA Spinal System Ref K153031
510(k) 510(k)EVEREST Spinal System Ref K161369
510(k) 510(k)Caspian OCT/MESA Mini/DENALI Mini Spinal System Ref K153370
510(k) 510(k)
Frequently asked questions
How many devices does K2m, Incorporated have in the registry?
The registry currently lists 3 devices for K2m, Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list K2m, Incorporated's devices?
Among its 3 most recently registered devices, K2m, Incorporated has devices listed in FDA 510(k) (3 devices).
What risk classes do K2m, Incorporated's devices fall under?
Among its 3 most recently registered devices, the classes recorded for K2m, Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from K2m, Incorporated in the registry?
The most recently registered devices listed for K2m, Incorporated include RANGE/DENALI/MESA Spinal System, EVEREST Spinal System and Caspian OCT/MESA Mini/DENALI Mini Spinal System.