Expedium Spine System

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 179972095Model EXPEDIUM Spine System Rod

by Medos International SARL

Identity

Trade Name: EXPEDIUM SPINE SYSTEM EUDAMED
EXPEDIUM FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: Straight rod, Rod, Commercially Pure Rod, Commercially Pure Rod with Hex Ends, Dual Diameter Rod, Dual Diameter Straight Rod, etc. EUDAMED
EXPEDIUM SPINE SYSTEM ROD, PRE-LORDOSED 6.35 x 95mm FDA UDI
Model / Reference: EXPEDIUM Spine System Rod EUDAMED
179972095 EUDAMEDFDA UDI
Description: EXPEDIUM SPINE SYSTEM ROD, PRE-LORDOSED 6.35 x 95mm FDA UDI

Identifiers

Catalog Number: 179972095 FDA UDI
Primary DI / UDI-DI: 10705034092096 EUDAMEDFDA UDI
Basic UDI-DI: 0705034a0016667 EUDAMED
FDA Product Code: NKB FDA UDI
KWP FDA UDI
OSH FDA UDI
MNI FDA UDI
MNH FDA UDI
KWQ FDA UDI
EMDN Code: P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
GMDN Term: Bone-screw internal spinal fixation system rod 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	0705034a0016667	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

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

Manufacturer

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

Sources (2)

EUDAMED 9d74f160-8756-45af-a25b-b591a6f83dee 61 fields · synced Jul 9, 2026
FDA UDI 3208637b-9784-49c5-800d-f8bbb7110aa5 35 fields · synced May 30, 2026