Identity
- Trade Name
- OrthAlign Plus EUDAMEDFDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Screw, 4.5mm dia x 20mm, 3.5mm Hex Head EUDAMEDFDA UDI
- Model / Reference
- 403108 EUDAMEDFDA UDI
- Description
- Screw, 4.5mm dia x 20mm, 3.5mm Hex Head FDA UDI
Identifiers
- Catalog Number
- 403108 FDA UDI
- Primary DI / UDI-DI
- 00858704006626 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00858704006626 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-00858704006626 | 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 fb1b459e-dfd4-4a2d-b8c9-27b50cc2d7cf 61 fields · synced May 29, 2026
- FDA UDI 9039f0de-326e-4125-a0f2-3ab9fd5c5bf1 35 fields · synced May 29, 2026