Skip to content

Evos 72402008N

by Smith & Nephew, Inc.

Evos 72402008N is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K213126 on 29 Sep 2022 (2 earlier submissions) and listed in FDA GUDID since 21 Sep 2015 (UDI-DI 00885556442098), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213126 Date29 Sep 2022DecidedStatusActive
United StatesGUDID listing Number00885556442098 UDI-DI Date21 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213126 decided 29 Sep 2022 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00885556442098 listed 21 Sep 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2945-2020 FDA Class II initiated 24 Aug 2020

    Multiple or incorrect expiration dates were provided on the affected designation labels.

    • Terminated Z-0408-2018 FDA Class II initiated 29 Nov 2017

    One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

Timeline

6 dated events

  1. Cleared FDA 510(k) K140814
  2. Listed FDA GUDID 00885556442098
  3. Recall initiated FDA recalls Z-0408-2018
  4. Recall initiated FDA recalls Z-2945-2020
  5. Cleared FDA 510(k) K210837
  6. Cleared FDA 510(k) K213126

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Evos
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
72402008N
Primary DI / UDI-DI
00885556442098
510(k) Number
FDA product code
HRS
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K140814)

and 8 more cleared under K140814

Cleared under the same submission (K210837)

and 8 more cleared under K210837

Similar devices in this category

Other devices filed under Orthopaedic bone screw (non-sliding).

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)