Bioalpha, Inc.
South KoreaFDA applicant, unverified
- Devices
- 1
What Bioalpha, Inc. makes
Bioalpha, Inc. manufactures the Bongros HA, a device designed for orthopedic applications, specifically for bone growth stimulation or fracture healing support.
The Bongros HA is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Bongros Ha Ref K090793
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioalpha, Inc. have in the registry?
The registry currently lists 1 device for Bioalpha, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioalpha, Inc.'s devices?
Among its 1 most recently registered device, Bioalpha, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Bioalpha, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bioalpha, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioalpha, Inc. in the registry?
The most recently registered devices listed for Bioalpha, Inc. include BONGROS HA.