Identity
- Trade Name
- OrthAlign Plus EUDAMEDFDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- OrthAlign Plus Unit- Gap Balancing EUDAMEDOrthAlign Plus Unit - Gap Balancing FDA UDI
- Model / Reference
- 403001-08 EUDAMEDFDA UDI
- Description
- OrthAlign Plus Unit - Gap Balancing FDA UDI
Identifiers
- Catalog Number
- 403001-08 FDA UDI
- Primary DI / UDI-DI
- 00810832031369 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810832031369 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- V0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic 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 UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
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
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-00810832031369 | 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 fadbd7b2-19e8-4ac8-8908-0838b40254a3 61 fields · synced Jul 12, 2026
- FDA UDI e3445338-3156-46c8-a39e-74cc9b43a6a4 36 fields · synced May 30, 2026