Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Met One Technologies — 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) |
|---|---|---|---|---|---|
| K193457 | AUDERE Lumbar Spacer System | Met One Technologies | 2020-05-12 | 148 | 0 |
| K180772 | Met One Czar Anterior Cervical Plate System | Met One Technologies | 2018-12-17 | 269 | 0 |
| K170108 | Xultan 5.5 Pedicle Screw System | Met One Technologies | 2017-05-02 | 110 | 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