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Medial Rotation Knee
EUDAMEDFDA UDIClass III (EU MDR)
Ref 156-624Model Medial Rotation KneeRef 156-114Ref 156-704Ref 156-747Ref 156-825Ref 156-611Ref 156-737Ref 156-749Ref 156-110Ref 156-741Ref 156-733Ref 156-743Ref 156-112Ref 156-703Ref 156-124Ref 156-713Ref 156-718Ref 156-123Ref 156-716Ref 156-121Ref 156-521Ref 156-701Ref 156-728Ref 156-712Ref 156-726Ref 156-721Ref 156-707Ref 156-122Ref 156-731Ref 156-724
Identity
- Trade Name
- Medial Rotation Knee EUDAMEDFDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- Medial Rotation Knee Bearing EUDAMEDMedial Rotation Knee Femur EUDAMEDMedial Rotation Knee All Poly Tibia EUDAMEDMedial Rotation Knee Patella EUDAMEDMedial Rotation Knee All Poly Knee EUDAMEDMedial Rotation Knee Right Tibial Insert Size 2 15.5mm FDA UDI
- Model / Reference
- Medial Rotation Knee EUDAMED156-624 EUDAMEDFDA UDI156-114 EUDAMED156-704 EUDAMED156-747 EUDAMED156-825 EUDAMED156-611 EUDAMED156-737 EUDAMED156-749 EUDAMED156-110 EUDAMED156-741 EUDAMED156-733 EUDAMED156-743 EUDAMED156-112 EUDAMED156-703 EUDAMED156-124 EUDAMED156-713 EUDAMED156-718 EUDAMED156-123 EUDAMED156-716 EUDAMED156-121 EUDAMED156-521 EUDAMED156-701 EUDAMED156-728 EUDAMED156-712 EUDAMED156-726 EUDAMED156-721 EUDAMED156-707 EUDAMED156-122 EUDAMED156-731 EUDAMED156-724 EUDAMED
- Description
- Medial Rotation Knee Right Tibial Insert Size 2 15.5mm FDA UDI
Identifiers
- Catalog Number
- 156-624 FDA UDI
- Primary DI / UDI-DI
- 05055455503922 EUDAMEDFDA UDI05055455503533 EUDAMED05055455504059 EUDAMED05055455504394 EUDAMED05055455504851 EUDAMED05055455503847 EUDAMED05055455504318 EUDAMED05055455504417 EUDAMED05055455503496 EUDAMED05055455504349 EUDAMED05055455504288 EUDAMED05055455504363 EUDAMED05055455503519 EUDAMED05055455504042 EUDAMED05055455503595 EUDAMED05055455504127 EUDAMED05055455504165 EUDAMED05055455503588 EUDAMED05055455504141 EUDAMED05055455503564 EUDAMED05055455503748 EUDAMED05055455504028 EUDAMED05055455504240 EUDAMED05055455504110 EUDAMED05055455504226 EUDAMED05055455504189 EUDAMED05055455504073 EUDAMED05055455503571 EUDAMED05055455504264 EUDAMED05055455504219 EUDAMED
- Basic UDI-DI
- B-05055455503922 EUDAMEDB-05055455503533 EUDAMEDB-05055455504059 EUDAMEDB-05055455504394 EUDAMEDB-05055455504851 EUDAMEDB-05055455503847 EUDAMEDB-05055455504318 EUDAMEDB-05055455504417 EUDAMEDB-05055455503496 EUDAMEDB-05055455504349 EUDAMEDB-05055455504288 EUDAMEDB-05055455504363 EUDAMEDB-05055455503519 EUDAMEDB-05055455504042 EUDAMEDB-05055455503595 EUDAMEDB-05055455504127 EUDAMEDB-05055455504165 EUDAMEDB-05055455503588 EUDAMEDB-05055455504141 EUDAMEDB-05055455503564 EUDAMEDB-05055455503748 EUDAMEDB-05055455504028 EUDAMEDB-05055455504240 EUDAMEDB-05055455504110 EUDAMEDB-05055455504226 EUDAMEDB-05055455504189 EUDAMEDB-05055455504073 EUDAMEDB-05055455503571 EUDAMEDB-05055455504264 EUDAMEDB-05055455504219 EUDAMED
- 510(k) Number
- K020214 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P090903020202 BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS EUDAMEDP0909030101 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS EUDAMEDP090903020301 BICOMPARTMENTAL PRIMARY IMPLANT TIBIAL COMPONENTS, MONOBLOCK MADE OF POLYETHYLENE EUDAMEDP0909070201 PATELLAR COMPONENTS, MONOBLOCK EUDAMED
- GMDN Term
- Tibial insert 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
EUDAMEDEUDAMED
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-05055455503922 | 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 (31)
- EUDAMED d69685be-43d1-4d8e-8279-0838a5483073 61 fields · synced Sep 17, 2026
- EUDAMED 4f6a7c54-296d-4be0-8b4d-709df8e0c8f9 61 fields · synced May 16, 2026
- EUDAMED 85229e92-9009-4cec-a8e6-42f284f97f15 61 fields · synced May 16, 2026
- EUDAMED b32dd9a9-ce5f-4e6a-b4e9-9a7da9880c42 61 fields · synced May 16, 2026
- EUDAMED 0c4857c7-624f-4cc9-b751-f3e3c1346c85 61 fields · synced May 16, 2026
- EUDAMED 3069ef35-b2a9-42b5-aa02-28a6b108a46f 61 fields · synced May 16, 2026
- EUDAMED d558289f-bffb-45e7-b6d9-5b5f01b6ec65 61 fields · synced May 16, 2026
- EUDAMED 2f182cdc-c9ee-48ba-bc9c-504e72a91311 61 fields · synced May 17, 2026
- EUDAMED c8e8d69b-d1a3-484b-ad14-1641cd144044 61 fields · synced May 17, 2026
- EUDAMED 8706c83c-0425-4b43-9f55-5f5cc4e26d36 61 fields · synced May 17, 2026
- EUDAMED 7f64fe41-0754-452c-999a-f73f2f893a64 61 fields · synced May 17, 2026
- EUDAMED 1d49a71c-6955-411c-923f-d975d7a16fb9 61 fields · synced May 17, 2026
- EUDAMED e87ca2d6-bdc4-46cb-9238-b7168b74dbbb 61 fields · synced May 17, 2026
- EUDAMED 24e665ad-2c84-4d0a-8bee-c6a9bdace8be 61 fields · synced May 17, 2026
- EUDAMED 08b00372-0aa9-4c29-b3ba-56f9d78569c6 61 fields · synced May 18, 2026
- EUDAMED 42acd53a-0653-4d25-891b-ec19d4fcae9b 61 fields · synced May 18, 2026
- EUDAMED e96cc0ba-80c9-449a-a082-8fbd4e580826 61 fields · synced May 18, 2026
- EUDAMED 531af423-6ccd-4e16-9d3b-412cfb79af2d 61 fields · synced May 18, 2026
- EUDAMED cfe71d2a-bcfa-4aac-815d-534077d206b7 61 fields · synced May 18, 2026
- EUDAMED 7d102eda-eb01-4ad6-86a8-ff334413d3af 61 fields · synced May 18, 2026
- EUDAMED 2dc641d3-da4a-4a13-86df-3b1b45852d88 61 fields · synced May 18, 2026
- EUDAMED c43d87ec-c9ee-4943-8a9c-9bb034e2b24d 61 fields · synced May 18, 2026
- EUDAMED 94876ad1-ca7c-4960-a6ec-0eea5f88fd66 61 fields · synced May 18, 2026
- EUDAMED 6e1da5e4-b05b-42d4-a225-829fd4e1f26b 61 fields · synced May 18, 2026
- EUDAMED 2930547e-aafc-4283-98ec-a1959ae5af3c 61 fields · synced May 19, 2026
- EUDAMED f0227200-b1d5-4226-8219-b0840a30fc0d 61 fields · synced May 19, 2026
- EUDAMED 782019b0-f17c-44ae-b09c-1d36cc7de68c 61 fields · synced May 19, 2026
- EUDAMED 24763c2d-ea73-4a98-b95a-32569aa35e11 61 fields · synced May 19, 2026
- EUDAMED 44c77c06-c739-4765-b4fd-20186ee8731d 61 fields · synced May 19, 2026
- EUDAMED ab161b82-f4e8-448b-8669-6dd6e6a5bd7a 61 fields · synced May 19, 2026
- FDA UDI 8c2e58ec-0ac2-45e1-aaff-746bc54086cc 35 fields · synced May 30, 2026