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Quantum
EUDAMEDFDA UDIClass I (EU MDR)
Ref M05 01481Model M05 00771
by In2Bones SAS
Identity
- Trade Name
- QUANTUM EUDAMEDFDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- QUANTUM IMPACTION FRAME TIBIAL IMPLANT TYPE II FDA UDI
- Model / Reference
- M05 00771 EUDAMEDM05 01481 EUDAMEDFDA UDI
- Description
- QUANTUM IMPACTION FRAME TIBIAL IMPLANT TYPE II FDA UDI
Identifiers
- Catalog Number
- M05 01481 FDA UDI
- Primary DI / UDI-DI
- 03701337609580 EUDAMEDFDA UDI
- Basic UDI-DI
- 3701337619537V EUDAMED
- Direct Marketing DI
- 03701337609580 EUDAMED
- 510(k) Number
- K191380 FDA UDI
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic instrument surgical connector 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Quantum by In2Bones SAS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 3701337619537V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (2)
- EUDAMED 5b81d3a6-ed27-4347-b63a-5303a7ebc13b 61 fields · synced May 30, 2026
- FDA UDI 6fc34292-ddb4-4fbf-9cda-fcd81196dcfb 36 fields · synced May 30, 2026