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EVOS Large Fragment Plating System

by Smith & Nephew, Inc. 2 variants

510(k) K201918

EVOS Large Fragment Plating System is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K201918 on 16 Nov 2020, active as of 22 Oct 2026. 4 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201918 Date16 Nov 2020ClearedStatusActive

Official records

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0363-2022 FDA Class II initiated 1 Nov 2021
    • Terminated Z-0365-2022 FDA Class II initiated 1 Nov 2021
    • Terminated Z-0364-2022 FDA Class II initiated 1 Nov 2021
    • Terminated Z-0366-2022 FDA Class II initiated 1 Nov 2021

    Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

Timeline

5 dated events

  1. Cleared FDA 510(k) K201918
  2. Recall initiated FDA recalls Z-0363-2022
  3. Recall initiated FDA recalls Z-0365-2022
  4. Recall initiated FDA recalls Z-0364-2022
  5. Recall initiated FDA recalls Z-0366-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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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