Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OQB · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2025-12-15 | 231 | 0 |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2023-11-01 | 212 | 0 |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2023-10-18 | 124 | 0 |
| DEN200010 | Spineology Interbody Fusion System | Spineology, Inc. | 2020-09-18 | 212 | 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