Epic Extremity Plate System— 510(k) K153340
Substantially EquivalentEpic Extremity, LLC
FDA 510(k) clearance K153340 for Epic Extremity Plate System, Substantially Equivalent on 2016-02-09. Applicant: Epic Extremity, LLC. Device class: 2.
Clearance details
- Applicant
- Epic Extremity, LLC
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cranberry Twp, PA, US
Recent devices under product code HRS
view allMore clearances from Epic Extremity, LLC
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K153340
K-number listed on FDA's recall record- Z-1874-2018 — Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
- Z-1875-2018 — 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)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153340.
Data sourced from openFDA. This site is unofficial and independent of the FDA.