Skip to content

Evos 72402722

by Smith & Nephew, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

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 Number00885556433744 UDI-DI Date21 Sep 2015ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
72402722
Primary DI / UDI-DI
00885556433744
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
MRI safety
MR Conditional
Size
Length — 22 Millimeter

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K140814)

Show all (12)

Cleared under the same submission (K210837)

Show all (12)

Cleared under the same submission (K213126)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No