Expedium Spine System

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 179712635Model EXPEDIUM Spine System Bone Screw

by Medos International SARL

Identity

Trade Name: EXPEDIUM SPINE SYSTEM EUDAMED
EXPEDIUM FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Polyaxial/Monoaxial/Uniplanar Screws Polyaxial/Uniplanar Extended Tab Screws Alar Bone Screw Cable/Wire Screw Fixed/Polyaxial Bolt EUDAMED
EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 6 x 35mm FDA UDI
Model / Reference: EXPEDIUM Spine System Bone Screw EUDAMED
179712635 EUDAMEDFDA UDI
Description: EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 6 x 35mm FDA UDI

Identifiers

Catalog Number: 179712635 FDA UDI
Primary DI / UDI-DI: 10705034067711 EUDAMEDFDA UDI
Basic UDI-DI: 0705034a0015766 EUDAMED
FDA Product Code: NKB FDA UDI
OSH FDA UDI
KWP FDA UDI
MNH FDA UDI
MNI FDA UDI
KWQ FDA UDI
EMDN Code: P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 FDA UDI
888.3060 FDA UDI
Market of Registration: Belgium EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal bone screw, non-bioabsorbable

Expedium Spine System by Medos International Sarl — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0705034a0015766	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

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Manufacturer

Manufacturer: Medos International SARL
EUDAMED SRN: CH-MF-000014268
Authorised Representative: DePuy Ireland UC IE-AR-000009328

Sources (2)

EUDAMED 19d74cdf-ce44-48ee-8f00-2218369c9782 61 fields · synced Jul 29, 2026
FDA UDI 0b4e51c3-ee82-492d-bb36-98e9387db6c2 35 fields · synced May 30, 2026