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Evos 72413510

by Smith & Nephew, Inc.

Evos 72413510 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 16 Jan 2017 (UDI-DI 00885556636862), active as of 23 Oct 2026. One FDA recall is 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

1 ongoing

This device is named in the recall

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 Number00885556636862 UDI-DI Date16 Jan 2017ListedStatusListed 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 00885556636862 listed 16 Jan 2017 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0265-2022 FDA Class II initiated 25 Oct 2021

    The labels on the packages of screws were switched.

Timeline

5 dated events

  1. Cleared FDA 510(k) K162078
  2. Listed FDA GUDID 00885556636862
  3. Cleared FDA 510(k) K210837
  4. Recall initiated FDA recalls Z-0265-2022
  5. 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  • Withdrawn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
72413510
Primary DI / UDI-DI
00885556636862
510(k) Number
FDA product code
HRS, HWC
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3030, 888.3040
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K162078)

and 8 more cleared under K162078

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

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)