Medtronic Spine, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Medtronic Spine, LLC makes
Medtronic Spine, LLC manufactures spinal fixation and correction devices, including the KYPHON Inflation Syringe—a tool for vertebral augmentation—and the KYPHON Anchor Facet Screw System, used for stabilizing facet joints in spinal procedures.
These products are regulated as Class II and Unclassified (U) devices under FDA requirements, with authorisation supported through 510(k) clearances. The company is based in the United States.
Catalogue
Kyphon Inflation Syringe Ref K103231
Regimes: 510(k) Registry: 510(k)Kyphon Anchor Facet Screw System Ref K101765
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtronic Spine, LLC have in the registry?
The registry currently lists 2 devices for Medtronic Spine, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Spine, LLC's devices?
Among its 2 most recently registered devices, Medtronic Spine, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Medtronic Spine, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Medtronic Spine, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic Spine, LLC in the registry?
The most recently registered devices listed for Medtronic Spine, LLC include KYPHON INFLATION SYRINGE and KYPHON ANCHOR FACET SCREW SYSTEM.