CG Bio Co., Ltd.
South KoreaFDA 510(k) applicant, unverified FDA FEI 3017036472
- Devices
- 65
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What CG Bio Co., Ltd. makes
CG Bio Co., Ltd. manufactures non-sterile bone-screw internal spinal fixation systems, including the LumFix Spinal Fixation System, designed for surgical stabilization of the spine.
The company’s devices are classified as Class II under FDA regulations and are recorded in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.
Catalogue
Search and filter all 65 devicesShowing 1-50 of 65
Company details
- FDA FEI number
- 3017036472
- DUNS number
- 631130655
- Address
- Part of C-dong, Part of D-dong, Hwaseong-si Gyeonggi
Frequently asked questions
How many devices does CG Bio Co., Ltd. have in the registry?
The registry currently lists 65 devices for CG Bio Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CG Bio Co., Ltd.'s devices?
Among its 50 most recently registered devices, CG Bio Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CG Bio Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for CG Bio Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from CG Bio Co., Ltd. in the registry?
The most recently registered devices listed for CG Bio Co., Ltd. include CURASYS 2 (EMDN0003), LumFix Spinal Fixation System CROSSB15076, LumFix spinal fixation system RDPS5030 and LumFix Spinal Fixation System DPS7540.