Expedium Sfx Cross Connector System
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- EXPEDIUM SFX CROSS CONNECTOR SYSTEM EUDAMEDEXPEDIUM SFX FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- End to End Dual Connector, Fixed Lateral Connector, Open/Closed Connector, SFX Cross Connector, Side by Side Dual Connector EUDAMEDEXPEDIUM SFX CROSS CONNECTOR SYSTEM LATERAL CONNECTOR P9 4.5 x 22mm FDA UDI
- Model / Reference
- EXPEDIUM Spine System Connector EUDAMED189407122 EUDAMEDFDA UDI
- Description
- EXPEDIUM SFX CROSS CONNECTOR SYSTEM LATERAL CONNECTOR P9 4.5 x 22mm FDA UDI
Identifiers
- Catalog Number
- 189407122 FDA UDI
- Primary DI / UDI-DI
- 10705034169712 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a001596A EUDAMED
- FDA Product Code
- KWQ FDA UDIMNI FDA UDIKWP FDA UDINKB FDA UDIMNH FDA UDIOSH FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3070 FDA UDI888.3050 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Spinal bone screw, non-bioabsorbable
Expedium Sfx Cross Connector 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a001596A | 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 9433b62b-7837-4ba3-947e-efef914f2efa 61 fields · synced Aug 2, 2026
- FDA UDI c099f4c9-eb49-4ab6-8f90-14451b4fba44 36 fields · synced May 30, 2026