General Spine System

EUDAMED

Class IIb (EU MDR)

Ref 45366040EModel Reduction Fixed-angle Screw,φ5.0×40

by Stryker Trauson (Changzhou) Medical Technology Co., Ltd.

Identity

Trade Name: General Spine System EUDAMED
Device Name: Reduction Fixed-angle Screw,φ5.0×40 EUDAMED
Model / Reference: Reduction Fixed-angle Screw,φ5.0×40 EUDAMED
45366040E EUDAMED

Identifiers

Primary DI / UDI-DI: 06931720437972 EUDAMED
Basic UDI-DI: B-06931720437972 EUDAMED
EMDN Code: P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED

Classification

Device Class: Class IIb EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

Yes

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

General Spine System by Stryker Trauson (Changzhou) Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06931720437972	Class IIb	Active

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Manufacturer

Manufacturer: Stryker Trauson (Changzhou) Medical Technology Co., Ltd.
EUDAMED SRN: CN-MF-000005689
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

EUDAMED f1f8650e-60c9-43c8-877f-9f21edd3dae8 61 fields · synced Sep 30, 2026