← Back to catalogue

4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 L14mm

EUDAMED

Class IIb (EU MDR)

Ref 1804014

by 4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti.

Identity

Device Name
4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 L14mm EUDAMED
Model / Reference
1804014 EUDAMED

Identifiers

Primary DI / UDI-DI
08682376505536 EUDAMED
Basic UDI-DI
B-08682376505536 EUDAMED
EMDN Code
P09070301 CERVICAL FIXATION SYSTEMS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

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: Cervical spine immobilization system, single-use

4U SPINAL POSTERIOR CERVICAL POLYAXIAL SCREW Ø:4.0 L14mm by 4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti. — Class IIb — MDD — listed in EUDAMED

Similar devices

Also classified as Cervical spine immobilization system, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti.
EUDAMED SRN
TR-MF-000040424

Sources (1)

  • EUDAMED ebac4e00-aa80-4e42-a82f-d6b66489923d 61 fields · synced Jul 9, 2026