Bacastow Tibial Plateau Starter Elevator
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Bacastow Tibial Plateau Starter Elevator EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- Retractor EUDAMEDBacastow Tibial Plateau Starter Elevator FDA UDI
- Model / Reference
- 5297 EUDAMEDFDA UDI
- Description
- Bacastow Tibial Plateau Starter Elevator FDA UDI
Identifiers
- Catalog Number
- 5297 FDA UDI
- Primary DI / UDI-DI
- 00840277120366 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNORETRACT016A EUDAMED
- Direct Marketing DI
- 00840277120366 EUDAMED
- FDA Product Code
- HTE FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Bone lever/elevator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Introducing the Bacastow Tibial Plateau Starter Elevator, a robust and reliable medical device designed for retraction of knee ligaments. This advanced device is engineered with cutting-edge technology to provide precise and controlled movement, making it an ideal solution for various medical applications.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8402771INNORETRACT016A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED f9ceaa49-9d22-4825-bdda-49d73b259605 61 fields · synced Aug 2, 2026
- FDA UDI e0140202-4ef0-4a76-b5b0-783b83bad6d5 34 fields · synced May 30, 2026