Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Citieffe S.R.L. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
322 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250197 | Estremo Fibular Nail | Citieffe S.R.L. | 2025-10-17 | 267 | 0 |
| K183666 | EBA One Nailing System | Citieffe S.R.L. | 2019-11-14 | 322 | 0 |
| K181540 | Estremo Citieffe Nailing System | Citieffe S.R.L. | 2019-01-16 | 219 | 0 |
| K180150 | PL8 Wrist Reconstruction Plate | Citieffe S.R.L. | 2018-08-02 | 195 | 0 |
| K163323 | Dolphix® External Fixation System MR Conditional | Citieffe S.R.L. | 2017-03-20 | 115 | 0 |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | 2015-07-07 | 116 | 0 |
| K132363 | DOLPHIX EXTERNAL FIXATION SYSTEM | Citieffe S.R.L. | 2014-01-16 | 170 | 0 |
| K131005 | EBA2 FEMORAL NAILING SYSTEM | Citieffe S.R.L. | 2013-06-25 | 75 | 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