Biogend Therapeutics Co., Ltd.
TaiwanFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Biogend Therapeutics Co., Ltd. makes
Biogend Therapeutics Co., Ltd. manufactures the BioGend Interbody Fusion System 001 Cage, a spinal interbody device designed for intervertebral fusion procedures in the lumbar or cervical spine. This product is intended to provide structural support and promote bone growth between vertebrae, aiding in the stabilization of spinal segments.
The BioGend Interbody Fusion System 001 Cage is classified as a Class II medical device under FDA regulations and has undergone the 510(k) clearance process. The company is based in the United States, and its devices are listed in the FDA’s 510(k) registry.
Catalogue
BioGend Interbody Fusion System 001 Cage Ref K233075
Regimes: 510(k) Registry: 510(k)
FDA establishments
- BioGend Therapeutics Co., Ltd Taipei City · TW FEI 3014346934
Frequently asked questions
How many devices does Biogend Therapeutics Co., Ltd. have in the registry?
The registry currently lists 1 device for Biogend Therapeutics Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biogend Therapeutics Co., Ltd.'s devices?
Among its 1 most recently registered device, Biogend Therapeutics Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Biogend Therapeutics Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biogend Therapeutics Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biogend Therapeutics Co., Ltd. in the registry?
The most recently registered devices listed for Biogend Therapeutics Co., Ltd. include “BioGend” Interbody Fusion System 001 Cage.
Which FDA establishments are linked to Biogend Therapeutics Co., Ltd.?
1 FDA establishment is linked to Biogend Therapeutics Co., Ltd. in the registry; they are listed on the company page.