CG Bio Co., Ltd.
Hwaseong-si Gyeonggi, KR
CG BIO CO., LTD. appears in FDA device records in Hwaseong-si Gyeonggi, KR. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for CG Bio Co., Ltd. between 2013 and 2026. The busiest year on record is 2026, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2016 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253199 | CURASYS 2 (EMDN0003) | OMP | Substantially Equivalent | |
| K252251 | EASYMADE-TI | GXN | Substantially Equivalent | |
| K250582 | COLONNADE Posterior Screw Fixation System | NKB | Substantially Equivalent | |
| K222229 | Advanced LumFix Spinal Fixation System | NKB | Substantially Equivalent | |
| K160731 | LumFix Spinal Fixation Sytem | MNI | Substantially Equivalent | |
| K122490 | KULAVAC | OMP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017036472 | 3017036472 | CG BIO CO., LTD. | Part of C-dong, Part of D-dong, Hwaseong-si Gyeonggi 18608 KR | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NECBandage, Liquid, Skin Protectant
- LYCBone Grafting Material, Synthetic
- PXOBone Marrow Biopsy Tray
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- MDAElastomer, Silicone, For Scar Management
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- GXNPlate, Cranioplasty, Preformed, Non-Alterable
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain