Skip to content

Na 56-90312

by Stryker Leibinger

Ref 56-90312Model 08858251002084SJ

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002084SJ Basic UDI-DI 07613327122954UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327122954 UDI-DI Date31 Mar 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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

Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device Name
Meshes Implants
Model / Ref / Catalog
56-90312, 08858251002084SJ
Primary DI / UDI-DI
07613327122954
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 market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional
Size
Length — 40.0 Millimeter
Width — 40.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

Cleared under the same submission (K161821)

Show all (12)

Cleared under the same submission (K170773)

Show all (12)

Other devices from Stryker Leibinger

See all devices from Stryker Leibinger →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No