Inion Hexalon™ Biodegradable ACL/PCL Screw

EUDAMED

Class III (EU MDR)

Ref SET-4000

by Inion Oy

Identity

Trade Name: Inion Hexalon™ Biodegradable ACL/PCL Screw EUDAMED
Device Name: Inion Hexalon ACL/PCL Screw EUDAMED
Model / Reference: SET-4000 EUDAMED

Identifiers

Primary DI / UDI-DI: 06438408002526 EUDAMED
Basic UDI-DI: B-06438408002526 EUDAMED
EMDN Code: P09120605 INTERFERENCE SCREWS EUDAMED

Classification

Device Class: Class III EUDAMED
Market of Registration: Finland 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: Tendon/ligament bone anchor, non-bioabsorbable

Inion Hexalon™ Biodegradable ACL/PCL Screw by Inion Oy — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.

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SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
JuggerKnot Soft Anchors — Biomet Orthopedics, 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-06438408002526	Class III	Active

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Manufacturer

Manufacturer: Inion Oy
EUDAMED SRN: FI-MF-000000646

Sources (1)

EUDAMED a8f1df45-1b8b-4980-b51a-2e918657cd48 61 fields · synced May 23, 2026