Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Epic Extremity with 5 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Feb 13, 2019: EPIC Extremity Fusion Plate System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Feb 13, 2019 | EPIC Extremity Fusion Plate SystemK182991 · HRS | 510(k) clearances |
| Mar 20, 2018 | 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)Class II · There is an error in the caddy artwork that misidentifies a specific plate and screw. | Device recalls |
| Mar 20, 2018 | Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)Class II · There is an error in the caddy artwork that misidentifies a specific plate and screw. | Device recalls |
| Nov 6, 2017 | EPIC Extremity Fracture Plate SystemK172441 · HRS | 510(k) clearances |
| Feb 28, 2017 | EPIC Extremity Snap-Off ScrewK163038 · HWC | 510(k) clearances |
| Feb 9, 2016 | Epic Extremity Plate SystemK153340 · HRS | 510(k) clearances |
| Jan 19, 2016 | Epic Extremity Cannulated Screw SystemK153333 · HWC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
