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56-90626

by Stryker Leibinger

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

Ref 56-90626Model 08858251002084SJ

56-90626 is a device classified as Class IIb in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI 08858251002084SJ), cleared under FDA 510(k) K170773 on 8 Nov 2017 (1 earlier submission) and listed in FDA GUDID since 31 Mar 2017 (UDI-DI 07613327123111), 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) K170773

+1 more

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 07613327123111UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170773 Date8 Nov 2017DecidedStatusActive
United StatesGUDID listing GUDID Number07613327123111 UDI-DI Date31 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002084SJ registered 8 Jul 2026 Active
  • FDA 510(k) K170773 decided 8 Nov 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07613327123111 listed 31 Mar 2017 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K161821
  2. Listed FDA GUDID 07613327123111
  3. Cleared FDA 510(k) K170773
  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  • Withdrawn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
56-90626, 08858251002084SJ
Primary DI / UDI-DI
07613327123111
Basic UDI-DI
08858251002084SJ
510(k) Number
FDA product code
GWO
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
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
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 (K161821)

and 8 more cleared under K161821

Cleared under the same submission (K170773)

and 8 more cleared under K170773

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

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)