Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dne, LLC — 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) |
|---|---|---|---|---|---|
| K151580 | D.N.E. External Fixation System | Dne, LLC | 2016-02-16 | 250 | 1 |
| K140158 | S.E.A.L. FRACTURE FUSION TUBE | Dne, LLC | 2014-05-29 | 127 | 0 |
| K113106 | DNE EXTERNAL FIXATION SYSTEM | Dne, LLC | 2012-01-04 | 76 | 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