Astra Orthomed, Inc.
United Statesfrom the FDA registration address FDA FEI 3041501961
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Astra Orthomed, Inc. makes
Astra Orthomed, Inc. manufactures the Phoenix Sinus Tarsi Stent System, a device designed for sinus tarsi stabilization in the foot to address conditions such as chronic ankle instability or ligamentous insufficiency.
The Phoenix Sinus Tarsi Stent System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) premarket notification process. The company is based in the United States.
Catalogue
Phoenix Sinus Tarsi Stent System Ref K251382
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3041501961
- Address
- 7842 Hickory Flat Hwy, Woodstock, GA, 30188
Frequently asked questions
How many devices does Astra Orthomed, Inc. have in the registry?
The registry currently lists 1 device for Astra Orthomed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Astra Orthomed, Inc.'s devices?
Among its 1 most recently registered device, Astra Orthomed, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Astra Orthomed, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Astra Orthomed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Astra Orthomed, Inc. in the registry?
The most recently registered devices listed for Astra Orthomed, Inc. include Phoenix Sinus Tarsi Stent System.