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56-90346S

by Stryker Leibinger

Part of a family of 42 devices: see the family page

Ref 56-90346SModel 08858251002084SJ

56-90346S is a craniofacial fixation plate (EU MDR Class IIb; FDA Class II) made by Stryker Leibinger, registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI 08858251002084SJ), cleared under FDA 510(k) K182425 on 6 Nov 2018 and listed in FDA GUDID since 19 Nov 2018 (UDI-DI 07613327382532), active as of 23 Oct 2026. One FDA recall is linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182425

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 Number08858251002084SJ Basic UDI-DI 07613327382532UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327382532 UDI-DI Date19 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK182425 Date6 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002084SJ registered 8 Jul 2026 Active
  • FDA 510(k) K182425 decided 6 Nov 2018 Active
  • FDA GUDID UDI-DI 07613327382532 listed 19 Nov 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1785-2024 FDA Class II initiated 29 Mar 2024

    Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

Timeline

4 dated events

  1. Cleared FDA 510(k) K182425
  2. Listed FDA GUDID 07613327382532
  3. Recall initiated FDA recalls Z-1785-2024
  4. Registered EUDAMED 08858251002084SJ

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  • Withdrawn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

Generic name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device name
Meshes Implants
Model / Ref / Catalog
56-90346S, 08858251002084SJ
Primary DI / UDI-DI
07613327382532
Basic UDI-DI
08858251002084SJ
510(k) Number
FDA product code
GWO, JEY
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.5320, 872.4760
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 120.0 Millimeter
Width — 120.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Craniofacial fixation plate, non-bioabsorbable, non-customized

Cleared under the same submission (K182425)

and 8 more cleared under K182425

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Stryker Leibinger

  • 92-55772

    Class II

  • 92-55773

    Class II

  • 92-55771

    Class II

  • 92-55770

    Class II

See all devices from Stryker Leibinger →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)