Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CG Bio Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
270 daysmedian FDA review time
455 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253199 | CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. | 2026-06-23 | 270 | 0 |
| K252251 | EASYMADE-TI | CG Bio Co., Ltd. | 2026-04-09 | 265 | 0 |
| K250582 | COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. | 2025-05-08 | 70 | 0 |
| K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | 2023-05-25 | 304 | 0 |
| K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016-10-04 | 201 | 0 |
| K122490 | KULAVAC | CG Bio Co., Ltd. | 2013-11-13 | 455 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda