Alpha Omega, Ltd.
Country not established
- Devices
- 5
What Alpha Omega, Ltd. makes
Alpha Omega, Ltd. manufactures medical devices for neurosurgery, including the Alpha Omega Dual Cooler-Heater for temperature-controlled tissue management, the NeuroTrek system for intraoperative physiological navigation, and the NeuroDrive and Neuronav systems for surgical guidance and motorized positioning. The Alpha Drive System supports motorized adjustments during procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Alpha Omega Dual Cooler-Heater Ref K001520
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Neurodrive System Ref K051830
Regimes: 510(k) Registry: 510(k)Neuronav System And Neuronav Drive Ref K071697
Regimes: 510(k) Registry: 510(k)Alpha Drive System Ref K013396
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alpha Omega, Ltd. have in the registry?
The registry currently lists 5 devices for Alpha Omega, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alpha Omega, Ltd.'s devices?
Among its 5 most recently registered devices, Alpha Omega, Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Alpha Omega, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Alpha Omega, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alpha Omega, Ltd. in the registry?
The most recently registered devices listed for Alpha Omega, Ltd. include ALPHA OMEGA DUAL COOLER-HEATER, NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY, NEURODRIVE SYSTEM and NEURONAV SYSTEM AND NEURONAV DRIVE.