# 56-90346S

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/na-56-90346s>
- Manufacturer: [Stryker Leibinger](https://devicerts.com/manufacturers/stryker-leibinger) (FDA registration: United States)
- Device class: Class IIb (EU MDR); Class II (US FDA)
- FDA product code: GWO, JEY
- EMDN: P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS
- GMDN: Craniofacial fixation plate, non-bioabsorbable, non-customized (46642)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 08858251002084SJ · UDI-DI 07613327382532 · registered 2026-07-08 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 07613327382532 · listed 2018-11-19 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K182425 · decision 2018-11-06 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1785-2024 · Class II · ongoing · initiated 2024-03-29: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

## Identity

- Generic name: Craniofacial fixation plate, non-bioabsorbable, non-customized [FDA GUDID (AccessGUDID)]
- Device name: Meshes Implants [EUDAMED]
- Model / Ref / Catalog: 56-90346S [EUDAMED, FDA GUDID (AccessGUDID)]; 08858251002084SJ [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 07613327382532 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 08858251002084SJ [EUDAMED]
- 510(k) Number: K182425 [FDA GUDID (AccessGUDID)]
- FDA product code: GWO [FDA GUDID (AccessGUDID)]; JEY [FDA GUDID (AccessGUDID)]
- EMDN code: P09120503 [EUDAMED]
- GMDN term: Craniofacial fixation plate, non-bioabsorbable, non-customized (46642) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.5320 [FDA GUDID (AccessGUDID)]; 872.4760 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Conditional [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Length — 120.0 Millimeter [FDA GUDID (AccessGUDID)]; Width — 120.0 Millimeter [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Implantable: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Sutures: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: 56-90346S, Stryker Leibinger. deviCERTS medical device catalogue. https://devicerts.com/devices/na-56-90346s (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/na-56-90346s.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/na-56-90346s
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.