Novaspine, LLC
United StatesFDA applicant, unverified
Part of NovaSpine
- Devices
- 3
What Novaspine, LLC makes
Novaspine, LLC manufactures suction pumps, including battery-powered and AC/DC-powered models designed for medical use, as well as a cement restrictor device for orthopedic applications. The suction pumps are intended for evacuating fluids during surgical procedures, while the cement restrictor is used in spinal surgeries to control bone cement flow.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Novaspine Powered Suction Pump Pro-1 Ref K062456
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Novaspine Cement Restrictor Nscr Ref K051607
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Novaspine, LLC have in the registry?
The registry currently lists 3 devices for Novaspine, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novaspine, LLC's devices?
Among its 3 most recently registered devices, Novaspine, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Novaspine, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Novaspine, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Novaspine, LLC in the registry?
The most recently registered devices listed for Novaspine, LLC include NOVASPINE POWERED SUCTION PUMP PRO-1, SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S and NOVASPINE CEMENT RESTRICTOR NSCR.