Smv Scientific: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Smv Scientific” (first 2015, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 128 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 |
|---|---|---|
| 2015 | 2 | 99 |
| 2016 | 2 | 135 |
| 2017 | 1 | 139 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Smv Scientific took a median 139 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 4 | 4 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Smv Scientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170021 | SMV Scientific Cannulated Screws | HWC | 2017-05-22 | 139 |
| K160946 | 4.0 and 6.5 Cancellous Bone Screw and Washer | HWC | 2016-12-05 | 244 |
| K160603 | SMV Scientific Schanz Screws | HWC | 2016-03-28 | 26 |
| K152000 | SMV Scientific Bone Plate and Screw System | HRS | 2015-11-25 | 128 |
| K150981 | SMV Scientific Bone Screws | HWC | 2015-06-23 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Smv Scientific.
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 Smv Scientific?
FDA lists 5 510(k) clearances under the applicant name “Smv Scientific” (first 2015, latest 2017), 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 Smv Scientific?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smv Scientific is 128 days.
Which FDA product codes appear under Smv Scientific?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 4); HRS (Plate, Fixation, Bone, 1).
Next steps
- See all 5 Smv Scientific clearances with predicates and recalls
- Run predicate analysis for product code HWC, Smv Scientific'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.