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Hoffmann 4933-1-010

by Stryker GmbH

Ref 4933-1-010Model 08858251002857TP

Hoffmann 4933-1-010 is a device classified as Class I in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI 08858251002857TP) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 07613252610304), active as of 12 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002857TP Basic UDI-DI 07613252610304UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252610304 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002857TP registered 14 Jul 2026 Active
  • FDA GUDID UDI-DI 07613252610304 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613252610304
  2. Registered EUDAMED 08858251002857TP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Hoffmann LRF™ EUDAMED
Hoffmann GUDID
Generic name
Implantable bone nut
Device name
Hlrf - Nuts - Class I - Non Sterile
Model / Ref / Catalog
4933-1-010, 08858251002857TP
Primary DI / UDI-DI
07613252610304
Basic UDI-DI
08858251002857TP
FDA product code
KTT
EMDN code
P09120499 External bone fixation systems - other
GMDN term
Implantable bone nut
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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.

Similar devices in this category

Other devices filed under EXTERNAL BONE FIXATION SYSTEMS - OTHER.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)