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Imhs 115174

by Smith & Nephew, Inc.

Imhs 115174 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K122170 on 19 Oct 2012 and listed in FDA GUDID since 25 Aug 2015 (UDI-DI 03596010052865), active as of 23 Oct 2026.

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

1 closed

Documents

510(k) K122170

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03596010052865 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122170 Date19 Oct 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122170 decided 19 Oct 2012 Active
  • FDA GUDID UDI-DI 03596010052865 listed 25 Aug 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0351-2020 FDA Class II initiated 7 Oct 2019 on shared 510(k) K122170

    LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K122170
  2. Listed FDA GUDID 03596010052865
  3. Recall initiated FDA recalls Z-0351-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Imhs
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Model / Ref / Catalog
115174
Primary DI / UDI-DI
03596010052865
510(k) Number
FDA product code
HSB
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Cleared under the same submission (K122170)

and 8 more cleared under K122170

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)