Fixano SA: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Fixano SA” (first 2001, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 45 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 | 4 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Fixano SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023314 | MICROFIX | KTT | 2002-10-18 | 45 |
| K022771 | TWIN FIX | KTT | 2002-09-23 | 33 |
| K012078 | RADIOFIX | KTT | 2001-09-27 | 87 |
| K012062 | PF2 | KTT | 2001-09-27 | 87 |
| K012161 | FLEX-NAILS | HTY | 2001-08-24 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Fixano SA.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Fixano SA?
FDA lists 5 510(k) clearances under the applicant name “Fixano SA” (first 2001, latest 2002), across 2 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 Fixano SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fixano SA is 45 days.
Which FDA product codes appear under Fixano SA?
The most frequent FDA product codes under this applicant name are KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 4); HTY (Pin, Fixation, Smooth, 1).
Next steps
- See all 5 Fixano SA clearances with predicates and recalls
- Run predicate analysis for product code KTT, Fixano SA'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.