Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eminent Spine, LLC — 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) |
|---|---|---|---|---|---|
| K240505 | Eminent Spine SI Screw System | Eminent Spine, LLC | 2024-06-04 | 104 | 0 |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | Eminent Spine, LLC | 2023-05-16 | 110 | 0 |
| K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021-11-05 | 59 | 0 |
| K201979 | Cervical Plate System | Eminent Spine, LLC | 2020-08-25 | 40 | 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