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Evos 72403555N

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

1 ongoing

This device is named in the recall

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 Number00885556638132 UDI-DI Date14 Mar 2017ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
72403555N
Primary DI / UDI-DI
00885556638132
510(k) Number
FDA product code
HWC, HRS
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3040, 888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

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Category: Orthopaedic bone screw (non-sliding)

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Cleared under the same submission (K213126)

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (10)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No