# CG Bio Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 6 (2013–2026): 6 510(k) clearances
- Product codes: NKB (2), OMP (2), GXN (1), MNI (1)
- 510(k) review time since 2016: median 265 days, against 141 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 6 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medyssey USA, Inc.: 1 (https://510kreport.com/company/medyssey-usa)
- Solco Biomedical Co., Ltd.: 1 (https://510kreport.com/company/solco-biomedical)
- Meticuly Co., Ltd.: 1 (https://510kreport.com/company/meticuly)
- Bioarchitects USA, LLC: 1 (https://510kreport.com/company/bioarchitects-usa)
- Medcad: 1 (https://510kreport.com/company/medcad)
- Medyssey Co, Ltd.: 1 (https://510kreport.com/company/medyssey)
- U&I Corporation: 1 (https://510kreport.com/company/u-i)
- Kinetic Concepts, Inc.: 1 (https://510kreport.com/company/kinetic-concepts)

## Firms that cite its devices most
- Osteomed Indústria E Comércio DE Implantes Ltda: 1 (https://510kreport.com/company/osteomed-industria-e-comercio-de-implantes)
- Tdm Co., Ltd.: 1 (https://510kreport.com/company/tdm)
- Medynus, Inc.: 1 (https://510kreport.com/company/medynus)

## Its most-cited devices
- K160731: LumFix Spinal Fixation Sytem (2016), cited by 4
- K222229: Advanced LumFix Spinal Fixation System (2023), cited by 2

## Recent decisions
- K253199: Curasys 2 (EMDN0003) (Jun 23, 2026)
- K252251: Easymade-TI (Apr 9, 2026)
- K250582: COLONNADE Posterior Screw Fixation System (May 8, 2025)
- K222229: Advanced LumFix Spinal Fixation System (May 25, 2023)
- K160731: LumFix Spinal Fixation Sytem (Oct 4, 2016)
- K122490: Kulavac (Nov 13, 2013)

Source page: https://510kreport.com/company/cg-bio