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Epic Extremity Plate System

by Epic Extremity, LLC 510(k)

Active United States

510(k) K153340

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153340 Date9 Feb 2016ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1874-2018 FDA Class II initiated 20 Mar 2018
    • Terminated Z-1875-2018 FDA Class II initiated 20 Mar 2018

    There is an error in the caddy artwork that misidentifies a specific plate and screw.

Specification

510(k)

510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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