Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ulrich Medical USA · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
163 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY | Ulrich Medical USA | 2023-10-20 | 122 | 0 |
| K230614 | Cortium™ | Ulrich Medical USA | 2023-05-02 | 57 | 0 |
| K223274 | Momentum® MIS Posterior Spinal Fixation System | Ulrich Medical USA | 2022-11-28 | 35 | 0 |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA | 2022-08-19 | 163 | 0 |
| K200845 | Navigation Module of the Momentum System | Ulrich Medical USA | 2020-09-10 | 163 | 0 |
| K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019-10-02 | 75 | 0 |
| K181921 | Solidity Vertebral Body Replacement | Ulrich Medical USA | 2018-11-16 | 121 | 0 |
| K150666 | uNion Cervical Plate System | Ulrich Medical USA | 2015-06-22 | 98 | 1 |
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