Haldor Advanced Technologies, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Haldor Advanced Technologies, Ltd. makes
Haldor Advanced Technologies, Ltd. manufactures the ORLOCATE System (Model ORL 100), a device designed for real-time surgical navigation and localization within operating rooms. This system is intended to assist in precise positioning of surgical instruments and implants, enhancing procedural accuracy during orthopedic and spinal surgeries.
The ORLOCATE System (Model ORL 100) is classified as a Class I medical device in the United States and is listed under the FDA’s 510(k) clearance pathway. The company is headquartered in the US.
Catalogue
Orlocate System Model Orl 100 Ref K100551
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Haldor Advanced Technologies, Ltd. have in the registry?
The registry currently lists 1 device for Haldor Advanced Technologies, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Haldor Advanced Technologies, Ltd.'s devices?
Among its 1 most recently registered device, Haldor Advanced Technologies, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Haldor Advanced Technologies, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Haldor Advanced Technologies, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Haldor Advanced Technologies, Ltd. in the registry?
The most recently registered devices listed for Haldor Advanced Technologies, Ltd. include ORLOCATE SYSTEM MODEL ORL 100.