Identity
- Trade Name
- ORTHOPILOT EUDAMEDFDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- ORTHOPILOT TKA implantation instr. IIa EUDAMEDORTHOPILOT STRAIGHT POINTER FDA UDI
- Model / Reference
- FS604 EUDAMEDFDA UDI
- Description
- ORTHOPILOT STRAIGHT POINTER FDA UDI
Identifiers
- Catalog Number
- FS604 FDA UDI
- Primary DI / UDI-DI
- 04038653350773 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000024572W EUDAMED
- Direct Marketing DI
- 04038653350773 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 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
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
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: Neurological stereotactic surgery system
Orthopilot by Aesculap AG — Class IIa — 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 | 40392390000024572W | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 6f797562-88d3-4a83-a860-3f93a936e3a0 61 fields · synced Jul 26, 2026
- FDA UDI b22fcbfd-f98e-472a-9c9a-7569cb4a7c2a 35 fields · synced May 30, 2026