Arex USA
Country not established
- Devices
- 3
What Arex USA makes
Arex USA manufactures headless compression screws, including the AREX SCRU 2 series (models P2P10 through P2P45), designed for orthopedic fixation. The company also produces the Ligamentotaxor, a device for ligament reconstruction or repair procedures.
The AREX SCRU 2 screws and Ligamentotaxor are classified as Class II medical devices under FDA regulations, with clearance via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
X-Fix Dynamic External Distractor Ref K122415
Regimes: 510(k) Registry: 510(k)Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 Ref K081011
Regimes: 510(k) Registry: 510(k)Ligamentotaxor Ref K094043
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Arex USA have in the registry?
The registry currently lists 3 devices for Arex USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arex USA's devices?
Among its 3 most recently registered devices, Arex USA has devices listed in FDA 510(k) (3 devices).
What risk classes do Arex USA's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Arex USA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Arex USA in the registry?
The most recently registered devices listed for Arex USA include X-FIX DYNAMIC EXTERNAL DISTRACTOR, AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 and LIGAMENTOTAXOR.