Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Citieffe — 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) |
|---|---|---|---|---|---|
| K113388 | CITIEFFE-TITANIUM CANNULATED SCREW | Citieffe | 2012-06-05 | 202 | 0 |
| K113384 | EXTERNAL FIXATOR ST.A R 90 F4 | Citieffe | 2012-05-01 | 167 | 0 |
| K113387 | CITIEFFE TITANIUM NAILING SYSTEM | Citieffe | 2012-03-15 | 120 | 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