Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Keos — 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) |
|---|---|---|---|---|---|
| K212450 | Keos Anterior Cervical Interbody Fusion Device System | Keos | 2022-06-06 | 305 | 0 |
| K193174 | Keos Lumbar IBFD | Keos | 2019-12-16 | 28 | 0 |
| K163386 | Keos Lumbar IBFD | Keos | 2017-04-10 | 129 | 0 |
| K160631 | Keos Lumbar IBFD | Keos | 2016-07-15 | 130 | 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