Identity
- Trade Name
- QUANTUM EUDAMEDFDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- QUANTUM Scroll Wheel For Insert Insertion FDA UDI
- Model / Reference
- M05 00811 EUDAMEDFDA UDI
- Description
- QUANTUM Scroll Wheel For Insert Insertion FDA UDI
Identifiers
- Catalog Number
- M05 00811 FDA UDI
- Primary DI / UDI-DI
- 03701337600815 EUDAMEDFDA UDI
- Basic UDI-DI
- 37013376195887 EUDAMED
- Direct Marketing DI
- 03701337600815 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 | 37013376195887 | 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 43f1c962-2146-4d95-b252-c2022783f5d4 61 fields · synced Jun 8, 2026
- FDA UDI 25a78e26-d829-43b8-99c8-b9d5b8f27b2f 36 fields · synced May 30, 2026