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Isola Spine System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 205027Model Expedium Offset Orthopaedic Surgery Cutting Instruments
Identity
- Trade Name
- ISOLA SPINE SYSTEM EUDAMEDISOLA FDA UDI
- Generic Name
- Orthopaedic implantable-device cutter FDA UDI
- Device Name
- Expedium Offset Instruments Knife Cutter EUDAMEDISOLA SPINE SYSTEM ROD CUTTER (SIDE) FDA UDI
- Model / Reference
- Expedium Offset Orthopaedic Surgery Cutting Instruments EUDAMED205027 EUDAMEDFDA UDI
- Description
- ISOLA SPINE SYSTEM ROD CUTTER (SIDE) FDA UDI
Identifiers
- Catalog Number
- 205027 FDA UDI
- Primary DI / UDI-DI
- 10705034001258 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a001245P EUDAMED
- Direct Marketing DI
- 10705034001258 EUDAMED
- FDA Product Code
- HTZ FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implantable-device cutter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone cutting forceps, reusable
Isola Spine System by Medos International Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0705034a001245P | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 cee30832-cbb0-4307-b3f4-be53f5e99c60 61 fields · synced Jul 13, 2026
- FDA UDI 67de9aba-20a4-466c-aff5-0f2bd37c8d2a 35 fields · synced May 30, 2026