Identity
- Trade Name
- OrthAlign Plus EUDAMEDFDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Femur Registration Marker, 3.5mm Hex EUDAMEDFDA UDI
- Model / Reference
- 403402 EUDAMEDFDA UDI
- Description
- Femur Registration Marker, 3.5mm Hex FDA UDI
Identifiers
- Catalog Number
- 403402 FDA UDI
- Primary DI / UDI-DI
- 00851977007840 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00851977007840 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- L0908 ORTHOPAEDIC AND TRAUMATOLOGICAL TRACTION INSTRUMENTS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
OrthAlign Plus 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-00851977007840 | 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 (2)
- EUDAMED d78c379d-99cc-4465-b7fc-6f5e7b7fa304 61 fields · synced Jun 6, 2026
- FDA UDI 6deac2ef-4eea-41ee-9361-f7c4d88c7f12 35 fields · synced May 30, 2026