CG Bio Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “CG Bio Co., Ltd.” (first 2013, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 268 days. Since 2017 the median was 268 days, against 86 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 455 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 201 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 304 |
| 2024 | 0 | — |
| 2025 | 1 | 70 |
| 2026 | 2 | 268 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name CG Bio Co., Ltd. took a median 268 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 86 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 2 | 2 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Review panels
- Orthopedic (3)
- General and Plastic Surgery (2)
- Neurology (1)
Most recent CG Bio Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253199 | CURASYS 2 (EMDN0003) | OMP | 2026-06-23 | 270 |
| K252251 | EASYMADE-TI | GXN | 2026-04-09 | 265 |
| K250582 | COLONNADE Posterior Screw Fixation System | NKB | 2025-05-08 | 70 |
| K222229 | Advanced LumFix Spinal Fixation System | NKB | 2023-05-25 | 304 |
| K160731 | LumFix Spinal Fixation Sytem | MNI | 2016-10-04 | 201 |
| K122490 | KULAVAC | OMP | 2013-11-13 | 455 |
Recalls
openFDA lists no recalls under a recalling firm named CG Bio Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under CG Bio Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “CG Bio Co., Ltd.” (first 2013, latest 2026), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by CG Bio Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name CG Bio Co., Ltd. is 268 days. Since 2017: 268 days, versus 86 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CG Bio Co., Ltd.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 2); OMP (Negative Pressure Wound Therapy Powered Suction Pump, 2); GXN (Plate, Cranioplasty, Preformed, Non-Alterable, 1).
Next steps
- See all 6 CG Bio Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NKB, CG Bio Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.