Miami Device Solutions, LLC: FDA clearances and approvals
Miami Device Solutions, LLC has 7 FDA 510(k) clearances (first 2015, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time: 98 days. Since 2017 its median was 84 days, against 94 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Miami Device Solutions, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 288 |
| 2016 | 3 | 98 |
| 2017 | 2 | 118 |
| 2018 | 1 | 68 |
| 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, Miami Device Solutions, LLC's cleared 510(k)s took a median 84 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 6 | 6 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Miami Device Solutions, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182810 | Distal Radius Plating System | HRS | 2018-12-10 | 68 |
| K172786 | MDS Plating System | HRS | 2017-12-08 | 84 |
| K162898 | Olecranon Plating System | HRS | 2017-03-17 | 151 |
| K162635 | Distal Radius Plating System | HRS | 2016-10-21 | 30 |
| K161292 | Distal Radius Plating System | HRS | 2016-08-15 | 98 |
| K161058 | Cannulated Screw | HWC | 2016-07-29 | 105 |
| K141493 | PROXIMAL HUMERUS PLATING SYSTEM | HRS | 2015-03-20 | 288 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-01-15.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Miami Device Solutions, LLC have?
Miami Device Solutions, LLC has 7 FDA 510(k) clearances (first 2015, latest 2018), across 2 product codes in 1 review panel.
How long does FDA take to clear Miami Device Solutions, LLC's 510(k)s?
The median time from FDA receipt to decision across Miami Device Solutions, LLC's cleared 510(k)s is 98 days. Since 2017: 84 days, versus 94 days for all cleared 510(k)s in the same product codes.
What devices does Miami Device Solutions, LLC make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 6); HWC (Screw, Fixation, Bone, 1).
Has Miami Device Solutions, LLC had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Miami Device Solutions, LLC; the most recent began 2019-01-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Miami Device Solutions, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Miami Device Solutions, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.