Citieffe S.R.L.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Citieffe S.R.L.” (first 2013, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 182 days. Since 2017 the median was 219 days, against 104 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 75 |
| 2014 | 1 | 170 |
| 2015 | 1 | 116 |
| 2016 | 0 | — |
| 2017 | 1 | 115 |
| 2018 | 1 | 195 |
| 2019 | 2 | 270 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 267 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Citieffe S.R.L. took a median 219 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 | 4 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Citieffe S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250197 | Estremo Fibular Nail | HSB | 2025-10-17 | 267 |
| K183666 | EBA One Nailing System | HSB | 2019-11-14 | 322 |
| K181540 | Estremo Citieffe Nailing System | HSB | 2019-01-16 | 219 |
| K180150 | PL8 Wrist Reconstruction Plate | HRS | 2018-08-02 | 195 |
| K163323 | Dolphix® External Fixation System MR Conditional | KTT | 2017-03-20 | 115 |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | JDW | 2015-07-07 | 116 |
| K132363 | DOLPHIX EXTERNAL FIXATION SYSTEM | KTT | 2014-01-16 | 170 |
| K131005 | EBA2 FEMORAL NAILING SYSTEM | HSB | 2013-06-25 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Citieffe S.R.L..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Citieffe (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Citieffe S.R.L.?
FDA lists 8 510(k) clearances under the applicant name “Citieffe S.R.L.” (first 2013, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Citieffe S.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Citieffe S.R.L. is 182 days. Since 2017: 219 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Citieffe S.R.L.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 4); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 2); HRS (Plate, Fixation, Bone, 1).
Next steps
- See all 8 Citieffe S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Citieffe S.R.L.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.