K7, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What K7, LLC makes
K7, LLC manufactures the K7C spacer, a device used in spinal surgery to maintain disc height and support vertebral alignment, as well as K7 lumbar spacers for interbody fusion procedures. The company also produces the Aversion Pedicle Screw System, designed for secure fixation in spinal stabilization surgeries.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance pathway. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
K7C Spacer Ref K123388
510(k) 510(k)K7 Lumbar Spacers Ref K133126
510(k) 510(k)Aversion Pedicle Screw System Ref K133103
510(k) 510(k)
Frequently asked questions
How many devices does K7, LLC have in the registry?
The registry currently lists 3 devices for K7, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list K7, LLC's devices?
Among its 3 most recently registered devices, K7, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do K7, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for K7, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from K7, LLC in the registry?
The most recently registered devices listed for K7, LLC include K7C SPACER, K7 LUMBAR SPACERS and AVERSION PEDICLE SCREW SYSTEM.