Pin K-Wire Ø 0.8 Lg 200 2 Tip

EUDAMED

Class IIb (EU MDR)

Ref 4.63.37Model WIRES

by Ortho Cape

Identity

Trade Name: PIN K-WIRE Ø 0.8 LG 200 2 TIP EUDAMED
Device Name: PIN K-WIRE Ø 0.8 LG 200 2 TIP EUDAMED
Model / Reference: WIRES EUDAMED
4.63.37 EUDAMED

Identifiers

Primary DI / UDI-DI: 03760347452296 EUDAMED
Basic UDI-DI: B-03760347452296 EUDAMED
EMDN Code: P09120301 KIRSCHNER BONE WIRES EUDAMED

Classification

Device Class: Class IIb EUDAMED
Market of Registration: France EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Orthopaedic bone pin, non-bioabsorbable

Pin K-Wire Ø 0.8 Lg 200 2 Tip by Ortho Cape — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

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XtraFix® External Fixation System — Zimmer, Inc. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, Inc. · Class II

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-03760347452296	Class IIb	Active

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Manufacturer

Manufacturer: Ortho Cape
EUDAMED SRN: FR-MF-000028862

Sources (1)

EUDAMED 3be30473-3069-4983-9749-3ff9adf8092a 61 fields · synced Aug 4, 2026