Data / Medical devices / South Korea / CG Bio Co., Ltd.
CG Bio Co., Ltd.: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 6 510(k) clearances
CG Bio Co., Ltd. is registered with the FDA (registration 3017036472) in Hwaseong-si Gyeonggi, South Korea. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 9, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017036472
- Address
- Part of C-dong, Part of D-dong 29, Jeyakdanji-ro, Hyangnam-eup, Manse-gu, Hwaseong-si Gyeonggi, South Korea, 18608
- Owner or operator
- CG Bio Co., Ltd. (10040923)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 3, 2012
- Registered through
- 2026
- Brand names listed
- ., 13 Nm Torque wrench, 5.5 Nm Torque wrench, 50-55 Cannula Ted Tapper, 60-65 Cannula Ted Tapper, 70-75 Cannula Ted Tapper, ?1.5 Guide Wire, Adjustment screw driver and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid, Skin Protectant | NEC | 1 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Bone Marrow Biopsy Tray | PXO | 1 | Manufacturer | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 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 |
|---|---|---|---|---|---|---|
| April 9, 2026 | K252251 | EASYMADE-TI | GXN | Substantially Equivalent | CG Bio Co., Ltd. | accessdata.fda.gov |
| May 8, 2025 | K250582 | COLONNADE Posterior Screw Fixation System | NKB | Substantially Equivalent | CG Bio Co., Ltd. | accessdata.fda.gov |
| May 25, 2023 | K222229 | Advanced LumFix Spinal Fixation System | NKB | Substantially Equivalent | CG Bio Co., Ltd. | accessdata.fda.gov |
| October 4, 2016 | K160731 | LumFix Spinal Fixation Sytem | MNI | Substantially Equivalent | CG Bio Co., Ltd. | accessdata.fda.gov |
| November 13, 2013 | K122490 | KULAVAC | OMP | Substantially Equivalent | CG Bio Co., Ltd. | accessdata.fda.gov |
| May 19, 2009 | K090793 | BONGROS HA | LYC | Substantially Equivalent | Bioalpha, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Marrow Biopsy Tray
- All makers of Bandage, Liquid, Skin Protectant
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Elastomer, Silicone, For Scar Management
Updated April 9, 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.