Universal Navigation Expedium Spine System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM EUDAMEDUNIVERSAL NAVIGATION EXPEDIUM EXPEDIUM VERSE FDA UDI
- Generic Name
- Stereotactic surgery system probe, reusable FDA UDI
- Device Name
- Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Probes, awls, drivers EUDAMEDUNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM EXPEDIUM VERSE POLYAXIAL DRIVER SHAFT, CANNULATED FDA UDI
- Model / Reference
- Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Orthopaedic Surgery Instruments EUDAMED2997-04-155N EUDAMEDFDA UDI
- Description
- UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM EXPEDIUM VERSE POLYAXIAL DRIVER SHAFT, CANNULATED FDA UDI
Identifiers
- Catalog Number
- 299704155N FDA UDI
- Primary DI / UDI-DI
- 10705034501444 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a001505Q EUDAMED
- Direct Marketing DI
- 10705034501444 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Stereotactic surgery system probe, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
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: Multi-purpose stereotactic surgery system
Universal Navigation Expedium Spine System by Medos International Sarl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140927 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0705034a001505Q | Class IIa | 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 177e56c0-880f-4f2f-964b-f8d1dacf9afc 85 fields · synced Jun 18, 2026
- FDA UDI 6a69955e-5635-432f-a700-fabec0e14069 36 fields · synced May 30, 2026
- FDA 510(k) K140927 1 fields · synced May 18, 2026