Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ulrich Medical USA, Inc. · 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) |
|---|---|---|---|---|---|
| K252087 | Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. | 2026-02-03 | 216 | 0 |
| K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025-07-01 | 27 | 0 |
| K241396 | uCerv Flux™-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA, Inc. | 2024-05-23 | 7 | 0 |
| K240515 | uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. | 2024-03-18 | 24 | 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