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Orthopilot Tha
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FS704Ref FS745Ref FS703Ref FS987RRef FS705Ref FS908RRef FS984RRef FS937RRef FS754Ref FS741Ref FS909RRef FS753Ref FS706RRef FS980Ref FS740Ref FS926Ref FS919R
by Aesculap AG
Identity
- Trade Name
- ORTHOPILOT THA EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDISurgical instrument/implant rack FDA UDI
- Device Name
- ORTHOPILOT THA instrument set EUDAMEDORTHOPILOT THA instrument IIa EUDAMEDORTHOPILOT THA tray EUDAMEDPLASMAFIT instrument IIa EUDAMEDORTHOPILOT THA EXTENSION F/C-CLAMP 60MM FDA UDIORTHOPILOT THA TRAY F/FS702-FS705 FDA UDIORTHOPILOT THA PIVOT BALL D32MM FDA UDI
- Model / Reference
- FS704 EUDAMEDFS745 EUDAMEDFS703 EUDAMEDFS987R EUDAMEDFS705 EUDAMEDFS908R EUDAMEDFDA UDIFS984R EUDAMEDFS937R EUDAMEDFS754 EUDAMEDFS741 EUDAMEDFS909R EUDAMEDFS706R EUDAMEDFDA UDIFS980 EUDAMEDFDA UDIFS753 EUDAMEDFS740 EUDAMEDFS926 EUDAMEDFS919R EUDAMED
- Description
- ORTHOPILOT THA EXTENSION F/C-CLAMP 60MM FDA UDIORTHOPILOT THA TRAY F/FS702-FS705 FDA UDIORTHOPILOT THA PIVOT BALL D32MM FDA UDI
Identifiers
- Catalog Number
- FS908R FDA UDIFS706R FDA UDIFS980 FDA UDI
- Primary DI / UDI-DI
- 04046963329990 EUDAMED04046963314316 EUDAMED04046963329983 EUDAMED04046963110659 EUDAMED04038653299515 EUDAMED04038653446346 EUDAMEDFDA UDI04038653465149 EUDAMED04038653350162 EUDAMED04046963314354 EUDAMED04046963314279 EUDAMED04038653446353 EUDAMED04046963336783 EUDAMEDFDA UDI04038653446391 EUDAMEDFDA UDI04046963314347 EUDAMED04046963314262 EUDAMED04038653416301 EUDAMED04046964163319 EUDAMED
- Basic UDI-DI
- 40392390000029353D EUDAMED40392390000014942V EUDAMED40392390000014902M EUDAMED40392390000019593L EUDAMED
- Direct Marketing DI
- 04038653446346 EUDAMED04046963336783 EUDAMED04046964163319 EUDAMED
- FDA Product Code
- LXH FDA UDIFSM FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDS010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMEDL091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDISurgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI878.4800 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
Yes
EUDAMEDEUDAMED
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 Tha 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 | 40392390000029353D | 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 (20)
- EUDAMED 1952102c-9499-4979-b5cf-bc26b136da1d 61 fields · synced Jul 28, 2026
- EUDAMED 5c87edb7-b0f8-4939-a682-860d7b4f12f0 61 fields · synced May 16, 2026
- EUDAMED c157c8cb-f6e0-43e9-967d-c8c319ba024a 61 fields · synced May 16, 2026
- EUDAMED 2627699c-7f33-487f-b60a-42a8e261d814 61 fields · synced May 16, 2026
- EUDAMED 0c4ad00a-977e-426a-ad6d-f431015a7ce6 61 fields · synced May 17, 2026
- EUDAMED 5fb756e4-024f-4a1b-bea6-c9d801f01ba8 61 fields · synced May 18, 2026
- EUDAMED bc5b1b67-30f3-4202-9b4c-7c91cba4c801 61 fields · synced May 18, 2026
- EUDAMED 89cde421-f27d-4e50-a042-6e62a4109470 61 fields · synced May 18, 2026
- EUDAMED 31968656-b9e0-40d1-95c9-b561a68c8ff1 61 fields · synced May 18, 2026
- EUDAMED 405f94f5-eb56-45d8-b683-d1273f08fac1 61 fields · synced May 18, 2026
- EUDAMED 53677b1a-b0d7-4769-81e3-9cb9de6b472c 61 fields · synced May 18, 2026
- FDA UDI d67be726-c74b-45c1-a6c3-d7558347dfb7 35 fields · synced May 30, 2026
- FDA UDI 72b0f343-20da-4839-b283-f64ea3ee9efa 35 fields · synced May 30, 2026
- FDA UDI 172c70c1-6ebd-4f35-ae39-4c9956aff5df 35 fields · synced May 30, 2026
- EUDAMED 566ddc5e-14aa-476e-808b-dd58e3f24db6 61 fields · synced Jul 10, 2026
- EUDAMED 4c364409-200d-4822-ba76-2a878e031634 61 fields · synced Jul 12, 2026
- EUDAMED 72347cb8-db5f-4d29-b7e4-d619c60819a3 61 fields · synced Jul 15, 2026
- EUDAMED 0e77d46f-774e-48e3-abf8-fca731ed583f 61 fields · synced Jul 16, 2026
- EUDAMED e1ae1958-206a-4373-922a-e4129ab9cabc 61 fields · synced Jul 21, 2026
- EUDAMED f12cb932-6807-4479-9d73-fc872eb9b3bc 61 fields · synced Jul 22, 2026