US Spine
Country not established
- Devices
- 5
What US Spine makes
Us Spine manufactures spinal fixation systems, including polyaxial and facet fixation devices, pedicle screw systems, and interbody cages. These products are designed for surgical stabilization of the spine, addressing conditions requiring internal fixation or segmental support.
The company’s portfolio includes devices classified as Class II and Unclassified (U) under FDA regulations, with submissions supported by 510(k) clearances. Products are listed in the FDA’s 510(k) database and are intended for use in the United States.
Catalogue
Ltd Polyaxial Fixation System Ref K062785
Regimes: 510(k) Registry: 510(k)Us Spine Facet Fixation System Ref K061041
Regimes: 510(k) Registry: 510(k)Preference Pedicle Screw System Ref K081296
Regimes: 510(k) Registry: 510(k)Modification To Preference Pedicle Screw System Ref K081883
Regimes: 510(k) Registry: 510(k)Phantom Plus Cage System Ref K082801
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Us Spine have in the registry?
The registry currently lists 5 devices for Us Spine. Devices recorded under merged duplicate company entries are counted once.
Which registries list Us Spine's devices?
Among its 5 most recently registered devices, Us Spine has devices listed in FDA 510(k) (5 devices).
What risk classes do Us Spine's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Us Spine's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Us Spine in the registry?
The most recently registered devices listed for Us Spine include LTD POLYAXIAL FIXATION SYSTEM, US SPINE FACET FIXATION SYSTEM, PREFERENCE PEDICLE SCREW SYSTEM and MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM.