Orthopedic Driven Imaging, LLC
United Statesfrom the FDA registration address FDA FEI 3045159436
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Orthopedic Driven Imaging, LLC makes
Orthopedic Driven Imaging, LLC produces the HipGuide, a device designed for imaging and guidance in orthopedic procedures involving the hip.
The HipGuide is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
HipGuide (V 1.0.0.0) Ref K260321
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3045159436
- DUNS number
- 026453686
- Address
- 4424 Nw 13th St Ste B6, Gainesville, FL, 32609
- [email protected]
- Phone
- 9016031309
Frequently asked questions
How many devices does Orthopedic Driven Imaging, LLC have in the registry?
The registry currently lists 2 devices for Orthopedic Driven Imaging, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthopedic Driven Imaging, LLC's devices?
Among its 2 most recently registered devices, Orthopedic Driven Imaging, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Orthopedic Driven Imaging, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Orthopedic Driven Imaging, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthopedic Driven Imaging, LLC in the registry?
The most recently registered devices listed for Orthopedic Driven Imaging, LLC include HipGuide V 1.0.0.0 and HipGuide (V 1.0.0.0).