510(k) K153340 ยท HRS Plate, Fixation, Bone
Epic Extremity Plate System
| Applicant | Epic Extremity, LLC, Cranberry Twp PA, US |
| Decision | Substantially Equivalent, Feb 9, 2016 |
| Received | Nov 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153340
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2018 | Epic Extremity, LLC Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002) Terminated |
HRS | None listed |
| Mar 20, 2018 | Epic Extremity, LLC Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N) Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.