Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Co-Ligne AG — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083567 | GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW | Co-Ligne AG | 2009-09-14 | 285 | 0 |
| K072326 | OSTAPEK VBR SYSTEM | Co-Ligne AG | 2008-06-24 | 309 | 0 |
| K051089 | GII SPINAL FIXATION SYSTEM | Co-Ligne AG | 2005-10-26 | 181 | 0 |
| K032604 | GII SPINAL FIXATION SYSTEM | Co-Ligne AG | 2004-01-20 | 148 | 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