Spineselect, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Spineselect, LLC makes
Spineselect, LLC manufactures the TURBO PRIME IBD SYSTEM, a device designed for internal bone drilling and fixation in spinal procedures, and the SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM, a pedicle screw system for spinal stabilization.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Turbo Prime Ibd System Ref K080058
Regimes: 510(k) Registry: 510(k)Spineselect Polyscrew Pedicle Screw System Ref K133066
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spineselect, LLC have in the registry?
The registry currently lists 2 devices for Spineselect, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spineselect, LLC's devices?
Among its 2 most recently registered devices, Spineselect, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Spineselect, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Spineselect, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spineselect, LLC in the registry?
The most recently registered devices listed for Spineselect, LLC include TURBO PRIME IBD SYSTEM and SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM.