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Spine Reference Array (4-Marker)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 55761A
by Brainlab SE
Identity
- Trade Name
- Spine Reference Array (4-Marker) EUDAMEDSPINE REFERENCE ARRAY (4 MARKER) FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- Spine & Trauma 3D Instruments EUDAMED
- Model / Reference
- 55761A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481142728 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056481142728 EUDAMED
- 510(k) Number
- K212245 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Neurological stereotactic surgery system
Spine Reference Array (4-Marker) by Brainlab SE — Class IIb — MDD, 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/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04056481142728 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 8bb9a14b-923b-4558-bc9d-d987d78e6359 61 fields · synced Jul 28, 2026
- FDA UDI ad403492-0bc6-44aa-8e6e-a7cede343fa1 33 fields · synced May 30, 2026