Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
K&J Consulting Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233332 | Statera-C™ Spinal System | K&J Consulting Corp. | 2023-11-27 | 59 | 0 |
| K232586 | Rexious Spinal Fixation System, Statera™ Spinal System, Stat | K&J Consulting Corp. | 2023-10-24 | 60 | 0 |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior | K&J Consulting Corp. | 2023-07-16 | 58 | 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