Medtronic Navigation Israel, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Medtronic Navigation Israel, Ltd. makes
Medtronic Navigation Israel, Ltd. manufactures the POLESTAR, Model N-30, a neurosurgical navigation system designed for intraoperative guidance in procedures such as craniotomies and spinal surgeries. This device integrates imaging data with real-time patient positioning to enhance precision during surgical interventions.
The POLESTAR, Model N-30 falls under Class II regulatory classification and has been authorised through the FDA’s 510(k) pathway. The company is based in the United States, and its devices are listed in the FDA’s 510(k) registry.
Catalogue
Polestar, Model N-30 Ref K092308
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtronic Navigation Israel, Ltd. have in the registry?
The registry currently lists 1 device for Medtronic Navigation Israel, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Navigation Israel, Ltd.'s devices?
Among its 1 most recently registered device, Medtronic Navigation Israel, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Medtronic Navigation Israel, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Medtronic Navigation Israel, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic Navigation Israel, Ltd. in the registry?
The most recently registered devices listed for Medtronic Navigation Israel, Ltd. include POLESTAR, MODEL N-30.