Identity
- Trade Name
- KneeAlign 2 EUDAMEDFDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDIOrthopaedic stereotactic surgery system FDA UDI
- Device Name
- KneeAlign 2 Unit EUDAMEDFDA UDITibial Cutting Block, Right EUDAMEDFDA UDI
- Model / Reference
- 133631 EUDAMED133631-01 EUDAMEDFDA UDI401578 EUDAMEDFDA UDI
- Description
- Tibial Cutting Block, Right FDA UDIKneeAlign 2 Unit FDA UDI
Identifiers
- Catalog Number
- 401578 FDA UDI133631-01 FDA UDI
- Primary DI / UDI-DI
- 00810832031376 EUDAMEDFDA UDI00858704006190 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810832031376 EUDAMEDB-00858704006190 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- V0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES EUDAMEDL0908 ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDIOrthopaedic stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMEDEUDAMED
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
Yes
EUDAMEDEUDAMED
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
No
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
KneeAlign 2 by Orthalign, Inc. — Class I — 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-00810832031376 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthAlign, Inc
- EUDAMED SRN
- US-MF-000027362
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED cef0b27e-b7f3-4e5c-8cff-6132aca0b244 61 fields · synced Jul 24, 2026
- FDA UDI d5b2c23d-5218-415d-8be9-a04793fa632d 35 fields · synced May 30, 2026
- FDA UDI 41865e4a-ae0d-4a6e-abd5-f9c005579e5f 36 fields · synced May 30, 2026
- EUDAMED 1f06965e-d9e6-41f1-b386-27970cc24925 61 fields · synced Jul 18, 2026