Data / Medical devices / South Korea / Hudens Bio Co., Ltd.
Hudens Bio Co., Ltd.: FDA-registered device maker in Gwangju, South Korea, 1 510(k) clearance
Hudens Bio Co., Ltd. is registered with the FDA (registration 3021666765) in Gwangju, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021666765
- Address
- 318 Cheomdanyeonsin-ro, Buk-gu, Gwangju, South Korea, 61088
- Owner or operator
- HUDENS BIO CO., LTD. (10095544)
- Roles
- Manufacturer
- First device listed
- March 29, 2026
- Registered through
- 2026
- Brand names listed
- BONTREE PLUS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 6, 2026 | K251818 | BONTREE PLUS | LYC | Substantially Equivalent | Hudens Bio Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.