Hudens Bio Co., Ltd.
South KoreaFDA applicant, unverified FDA FEI 3021666765
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Hudens Bio Co., Ltd. makes
Hudens Bio Co., Ltd. manufactures the BONTREE PLUS, a medical device designed for orthopedic applications, including bone grafting and spinal fusion procedures.
The BONTREE PLUS is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Bontree Plus Ref K251818
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3021666765
- Address
- 318 Cheomdanyeonsin-ro, Buk-gu, Gwangju
Frequently asked questions
How many devices does Hudens Bio Co., Ltd. have in the registry?
The registry currently lists 1 device for Hudens Bio Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hudens Bio Co., Ltd.'s devices?
Among its 1 most recently registered device, Hudens Bio Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Hudens Bio Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hudens Bio Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hudens Bio Co., Ltd. in the registry?
The most recently registered devices listed for Hudens Bio Co., Ltd. include BONTREE PLUS.