Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medynus, Inc. — 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) |
|---|---|---|---|---|---|
| K220379 | IMPEACE and IMPEACE-Uni Anterior Cervical Plate System | Medynus, Inc. | 2022-03-03 | 21 | 0 |
| K212792 | Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | Medynus, Inc. | 2021-09-23 | 22 | 0 |
| K210420 | Goblin and Goblin LS Pedicle Screw Systems | Medynus, Inc. | 2021-04-19 | 67 | 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