510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Epic Extremity, LLC

Cranberry Twp, PA, US

Epic Extremity, LLC appears in FDA device records in Cranberry Twp, PA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

FDA records hold 5 510(k) clearances for Epic Extremity, LLC between 2016 and 2019. The busiest year on record is 2016, with 2. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Epic Extremity, LLC, by decision year
YearClearances
20162
20172
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K182991EPIC Extremity Fusion Plate SystemHRSSubstantially Equivalent
K172441EPIC Extremity Fracture Plate SystemHRSSubstantially Equivalent
K163038EPIC Extremity Snap-Off ScrewHWCSubstantially Equivalent
K153340Epic Extremity Plate SystemHRSSubstantially Equivalent
K153333Epic Extremity Cannulated Screw SystemHWCSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1875-2018Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)There is an error in the caddy artwork that misidentifies a specific plate and screw.Class IITerminated
Z-1874-2018Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)There is an error in the caddy artwork that misidentifies a specific plate and screw.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain