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Epic Extremity, LLC

United StatesFDA applicant, unverified

Devices
5
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Epic Extremity, LLC makes

Epic Extremity, LLC manufactures orthopedic fixation systems for long bone fractures and limb stabilization, including locking and non-locking fracture plates, cannulated screws, and snap-off screws designed for internal fixation. Their product portfolio also includes specialized fusion plates for spinal and extremity applications, intended for surgical use in trauma and reconstructive procedures.

The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to compliance with the FDA’s medical device authorization requirements.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Epic Extremity, LLC, initiated on 2018-03-20. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 2
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2018

    • 20 Mar 2018 Z-1874-2018 Class II Terminated There is an error in the caddy artwork that misidentifies a specific plate and screw. Distribution: The products were distributed to the following US states: FL, PA, and VA. Submission number: K153340
    • 20 Mar 2018 Z-1875-2018 Class II Terminated There is an error in the caddy artwork that misidentifies a specific plate and screw. Distribution: The products were distributed to the following US states: FL, PA, and VA. Submission number: K153340

Frequently asked questions

How many devices does Epic Extremity, LLC have in the registry?

The registry currently lists 5 devices for Epic Extremity, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Epic Extremity, LLC's devices?

Among its 5 most recently registered devices, Epic Extremity, LLC has devices listed in FDA 510(k) (5 devices).

What risk classes do Epic Extremity, LLC's devices fall under?

Among its 5 most recently registered devices, the classes recorded for Epic Extremity, LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Epic Extremity, LLC?

FDA recall records list 2 recalls initiated by Epic Extremity, LLC, the most recent initiated on 2018-03-20. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Epic Extremity, LLC in the registry?

The most recently registered devices listed for Epic Extremity, LLC include EPIC Extremity Fracture Plate System, EPIC Extremity Snap-Off Screw, Epic Extremity Cannulated Screw System and Epic Extremity Plate System.

Generated automatically from registry data and not verified by a human reviewer.