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Medial Rotation Knee
EUDAMEDFDA UDIClass III (EU MDR)
Ref 156-384Model Medial Rotation Knee
Identity
- Trade Name
- Medial Rotation Knee EUDAMEDFDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, metallic FDA UDI
- Device Name
- Medial Rotation Knee Tibial Tray EUDAMEDMedial Rotation Knee Tibia Metal Back T4 80 Stem FDA UDI
- Model / Reference
- Medial Rotation Knee EUDAMED156-384 EUDAMEDFDA UDI
- Description
- Medial Rotation Knee Tibia Metal Back T4 80 Stem FDA UDI
Identifiers
- Catalog Number
- 156-384 FDA UDI
- Primary DI / UDI-DI
- 05055455503670 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055455503670 EUDAMED
- 510(k) Number
- K020214 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P090903020104 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FIXED BEARING TIBIAL PLATES EUDAMED
- GMDN Term
- Uncoated knee tibia prosthesis, metallic FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Medial Rotation Knee by MatOrtho Limited — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05055455503670 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- MatOrtho Limited
- EUDAMED SRN
- GB-MF-000007614
- Authorised Representative
- MatOrtho Ireland Limited IE-AR-000006856
Sources (2)
- EUDAMED 43156b38-e48c-47df-9937-54a7d23647a7 61 fields · synced Jul 9, 2026
- FDA UDI 4a092077-5f15-4ad8-b5e7-2ba154aced65 35 fields · synced May 30, 2026