Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OJB · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151360 | Inion Spinal Graft Containment System | Inion OY | 2015-10-06 | 139 | 0 |
| K071810 | INION SPINAL GRAFT CONTAINMENT SYSTEM | Inion , Ltd. | 2008-07-11 | 375 | 0 |
| K051821 | INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM | Inion , Ltd. | 2005-11-25 | 143 | 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