Epic Extremity, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Epic Extremity, LLC” (first 2016, latest 2019), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 87 days. Since 2017 the median was 107 days, against 94 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 |
|---|---|---|
| 2016 | 2 | 72 |
| 2017 | 2 | 104 |
| 2018 | 0 | — |
| 2019 | 1 | 107 |
| 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 Epic Extremity, LLC took a median 107 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 | 3 | 3 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
Review panels
- Orthopedic (5)
Most recent Epic Extremity, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182991 | EPIC Extremity Fusion Plate System | HRS | 2019-02-13 | 107 |
| K172441 | EPIC Extremity Fracture Plate System | HRS | 2017-11-06 | 87 |
| K163038 | EPIC Extremity Snap-Off Screw | HWC | 2017-02-28 | 120 |
| K153340 | Epic Extremity Plate System | HRS | 2016-02-09 | 82 |
| K153333 | Epic Extremity Cannulated Screw System | HWC | 2016-01-19 | 61 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-03-20.
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.
- Epic Medical Pte. , Ltd. (22 510(k)s)
- Epic Medical Equipment Services, Inc. (13 510(k)s)
- Epic Systems, Inc. (4 510(k)s)
- Epic Extremely, LLC (1 510(k)s)
- Epic Medical Concepts & Innovations (1 510(k)s)
- Epic Research & Diagnostics, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Epic Extremity, LLC?
FDA lists 5 510(k) clearances under the applicant name “Epic Extremity, LLC” (first 2016, latest 2019), 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 Epic Extremity, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Epic Extremity, LLC is 87 days. Since 2017: 107 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Epic Extremity, LLC?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 3); HWC (Screw, Fixation, Bone, 2).
Next steps
- See all 5 Epic Extremity, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Epic Extremity, LLC'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.