Uni FB tibial component LM/RL
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Uni FB EUDAMEDUni FB tibial component LM/RL FDA UDIUni FB joint gap check FDA UDIPB Uni tibial trial insert FDA UDI
- Generic Name
- Uncoated unicondylar knee tibia prosthesis, metallic FDA UDIAbdominal/ENT/orthopaedic surgical probe, reusable FDA UDIKnee tibia prosthesis trial, reusable FDA UDI
- Device Name
- - EUDAMED
- Model / Reference
- 42160382 EUDAMEDFDA UDI40120109 EUDAMEDFDA UDIKNU15FBCINST EUDAMEDKNU12FBTTIINST EUDAMED40100027 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844544522 EUDAMEDFDA UDI04048844030940 EUDAMEDFDA UDI04048844480073 FDA UDI
- Basic UDI-DI
- 4048844KNU15FBCINST35 EUDAMED4048844KNU12FBTTIINST6S EUDAMED
- Direct Marketing DI
- 04048844544522 EUDAMED
- FDA Product Code
- HSX FDA UDILXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Uncoated unicondylar knee tibia prosthesis, metallic FDA UDIAbdominal/ENT/orthopaedic surgical probe, reusable FDA UDIKnee tibia prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3520 FDA UDI888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Uncoated unicondylar knee tibia prosthesis, metallic
Uni FB tibial component LM/RL by implantcast GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- implantcast GmbH
Sources (5)
- FDA UDI 6f39e361-5d53-4506-b6b1-4db37cd8eb2b 33 fields · synced Jul 8, 2026
- FDA UDI ec7ba125-a721-4b18-9bf7-ae29cd6f28c2 33 fields · synced May 24, 2026
- FDA UDI e7f4ee4a-c566-46fb-997e-257bd751573a 33 fields · synced May 29, 2026
- EUDAMED 5d94f843-c6fa-49d3-8efd-d2397574d440 61 fields · synced Jul 8, 2026
- EUDAMED 10b33bb9-498e-43b9-bbc5-a419ed006cb6 61 fields · synced Jul 8, 2026