Expedium Spine System

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 179712250Model EXPEDIUM Spine System Bone Screw510(k) K130877

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 POLYAXIAL SCREW 5.5 x 11 x 50mm FDA UDI
Model / Reference: EXPEDIUM Spine System Bone Screw EUDAMED
179712250 EUDAMEDFDA UDI
Description: EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 x 11 x 50mm FDA UDI

Identifiers

Catalog Number: 179712250 FDA UDI
Primary DI / UDI-DI: 10705034067018 EUDAMEDFDA UDI
Basic UDI-DI: 0705034a0015766 EUDAMED
510(k) Number: K101993 FDA UDI
FDA Product Code: NKB FDA UDI
KWQ FDA UDI
MNH FDA UDI
MNI FDA UDI
KWP 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
888.3060 FDA UDI
888.3050 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

The Expedium Spine System is a class IIb orthopedic device designed for spinal fixation, including polyaxial, monoaxial, and uniplanar screws, extended tab screws, alar bone screws, cable/wire screws, and fixed/polyaxial bolts. It is intended for noncervical pedicle and nonpedicle fixation in spinal procedures, supporting stabilization in degenerative disc disease and other spinal pathologies.

This system is supplied as a single-use, implantable device and is non-reusable. It is not pre-sterilized and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The device is regulated under FDA 510K clearance and MDR compliance, with a UDI (10705034067018) for traceability. Available in various configurations, it is intended for use in controlled surgical environments by trained professionals.

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

Frequently asked questions

What is the Expedium Spine System used for?

The Expedium Spine System is designed for spinal fixation, including polyaxial, monoaxial, and uniplanar screws, extended tab screws, alar bone screws, cable/wire screws, and fixed/polyaxial bolts. It is intended for noncervical pedicle and nonpedicle fixation in spinal procedures, supporting stabilization in degenerative disc disease and other spinal pathologies.

Is the Expedium Spine System reusable or single-use?

The Expedium Spine System is supplied as a single-use, implantable device and is non-reusable. It must be sterilized prior to use, adhering to standard medical device sterilization protocols, as it is not pre-sterilized.

What regulatory approvals does the Expedium Spine System have?

The Expedium Spine System is regulated under FDA 510K clearance and MDR compliance. It has a UDI (10705034067018) for traceability and is classified as a Class IIb orthopedic device.

What configurations are available for the Expedium Spine System?

The Expedium Spine System is available in various configurations including polyaxial/monoaxial/uniplanar screws, extended tab screws, alar bone screws, cable/wire screws, and fixed/polyaxial bolts. It is intended for use in controlled surgical environments by trained professionals.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EXPEDIUM Spine System - SPINEMarketGroup, EXPEDIUM SPINE SYSTEM (UDI: 10705034211848) Specs & FDA Data, PDF Medos International Sàrl ℅ Rhoda Maddonni Regulatory Scientist, Global ...

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K130877	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K101070	Class IIb	Active
EUDAMED	European Union	CE/MDR	0705034a0015766	Class IIb	Active

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Manufacturer

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

Sources (3)

EUDAMED fa43900b-dc1d-40c9-806f-954d07ec0a9d 85 fields · synced Sep 19, 2026
FDA UDI cdc87b32-644a-473f-90e8-2c50dfe0bcad 36 fields · synced May 30, 2026
FDA 510(k) K130877 1 fields · synced May 18, 2026