Identity
- Trade Name
- ORTHOPILOT EUDAMEDAESCULAP FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- ORTHOPILOT THA pointer EUDAMEDORTHOPILOT ACL FEMORAL PUNCH FDA UDI
- Model / Reference
- FS869R EUDAMEDFDA UDI
- Description
- ORTHOPILOT ACL FEMORAL PUNCH FDA UDI
Identifiers
- Catalog Number
- FS869R FDA UDI
- Primary DI / UDI-DI
- 04038653332748 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000029343B EUDAMED
- FDA Product Code
- HWP FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable 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
Similar devices
Also classified as Neurological stereotactic surgery system.
- Gauge for Softouch Registration Pointer — Brainlab SE · Class I
- PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
- Mini-Bolt VUE Accessory Kit — MONTERIS MEDICAL CORP · Class I
- StealthAiR™ Spine — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
- OsteoMed™ Manual Driver Handle — FHC, INC. · Class II
- PMT CORPORATION - STEREOTACTIC — Pmt Corp. · Class II
- Leksell Stereotactic System — Elekta Instrument AB · Class II
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 | 40392390000029343B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED c10fc1c7-8d8c-4379-b58d-a7e472e6c2fe 61 fields · synced Jun 18, 2026
- FDA UDI 47cc8cd8-521e-4315-a91e-191f2de61165 35 fields · synced May 30, 2026