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Synapse

EUDAMED

Class IIb (EU MDR)

Ref 498.937Model Connecting Rods for Spine Titanium Connecting Rod

by Synthes GmbH

Identity

Trade Name
SYNAPSE EUDAMED
Device Name
Titanium Connecting Rod EUDAMED
Model / Reference
Connecting Rods for Spine Titanium Connecting Rod EUDAMED
498.937 EUDAMED

Identifiers

Primary DI / UDI-DI
07611819737495 EUDAMED
Basic UDI-DI
7611819a00442JL EUDAMED
EMDN Code
P09070304 SPINE FIXATION SYSTEM CONNECTORS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Bone-screw internal spinal fixation system connector

Synapse by Synthes GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Synthes GmbH
EUDAMED SRN
CH-MF-000013345
Authorised Representative
DePuy Ireland UC IE-AR-000009328

Sources (1)

  • EUDAMED b6645e7a-a2d9-42af-8397-d6fe1a521273 61 fields · synced Jun 18, 2026