Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coligne 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) |
|---|---|---|---|---|---|
| K210306 | GII Spinal Fixation System | Coligne AG | 2021-05-19 | 105 | 0 |
| K181963 | ostaPek Interbody Fusion Cages | Coligne AG | 2018-11-14 | 114 | 0 |
| K173893 | Trabis | Coligne AG | 2018-09-06 | 259 | 0 |
| K173148 | ACIF | Coligne AG | 2017-12-01 | 63 | 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