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Hoffmann 4922-9-950

by Stryker Corp.

Ref 4922-9-950Model 08858251002874TP

Hoffmann 4922-9-950 is a device classified as Class I in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 08858251002874TP), cleared under FDA 510(k) K122284 on 24 Oct 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07613252505877), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122284

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002874TP Basic UDI-DI 07613252505877UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252505877 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122284 Date24 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002874TP registered 10 Sep 2026 Active
  • FDA 510(k) K122284 decided 24 Oct 2012 Active
  • FDA GUDID UDI-DI 07613252505877 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122284
  2. Listed FDA GUDID 07613252505877
  3. Registered EUDAMED 08858251002874TP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Hoffmann
Generic name
Instrument tray, reusable
Device name
Hoffmann 3 - Trays and Tray Accessories - Class I - Non Sterile
Model / Ref / Catalog
4922-9-950, 08858251002874TP
Primary DI / UDI-DI
07613252505877
Basic UDI-DI
08858251002874TP
Direct marketing DI
07613252505877
FDA product code
KTT
EMDN code
P09120499 External bone fixation systems - other
GMDN term
Instrument tray, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K122284)

and 8 more cleared under K122284

Similar devices in this category

Other devices filed under EXTERNAL BONE FIXATION SYSTEMS - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)