Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Curiteva, 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) |
|---|---|---|---|---|---|
| K181589 | Curiteva Lumbar Interbody Fusion System | Curiteva, LLC | 2018-12-20 | 185 | 0 |
| K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva | Curiteva, LLC | 2018-08-03 | 52 | 0 |
| K181562 | Curiteva Anterior Cervical Plate System | Curiteva, LLC | 2018-08-02 | 49 | 0 |
| K181261 | Curiteva Cervical Interbody Fusion System | Curiteva, LLC | 2018-07-09 | 59 | 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