Serrano Intl.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Serrano Intl.” (first 1981, latest 1985), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 2 | 2 |
| FTM | Mesh, Surgical | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Serrano Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851409 | UNILOC TOTAL HIP PROSTHESIS | — | 1985-11-22 | 227 |
| K820899 | MECRON VOORHOEVE TITANIUM SHEATH | — | 1982-05-14 | 44 |
| K820619 | MECRON(R) ACETABULAR NETS TM | FTM | 1982-05-14 | 67 |
| K820852 | MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY | HSB | 1982-04-15 | 20 |
| K810497 | BONE FIXACTION SCREW | HWC | 1981-03-11 | 15 |
| K810205 | MECRON CANCELLOUS CANNULATED BONE SCREWS | HWC | 1981-02-09 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Serrano Intl..
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 Serrano Intl.?
FDA lists 6 510(k) clearances under the applicant name “Serrano Intl.” (first 1981, latest 1985), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Serrano Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Serrano Intl. is 32 days.
Which FDA product codes appear under Serrano Intl.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 2); FTM (Mesh, Surgical, 1); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Next steps
- See all 6 Serrano Intl. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Serrano Intl.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.