Identity
- Trade Name
- VEA FDA UDI
- Generic Name
- Orthopaedic/craniofacial implantation planning software FDA UDI
- Device Name
- Vea - Mobile Alignment App FDA UDI
- Model / Reference
- AIX21000 FDA UDI
- Description
- Vea - Mobile Alignment App FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376470351 FDA UDI
- 510(k) Number
- K211987 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Orthopaedic/craniofacial implantation planning software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic/craniofacial implantation planning software
Vea by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic/craniofacial implantation planning software.
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- OrthoView — Meridian Technique, Ltd. · Class II
- OrthoView — Meridian Technique, Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI 7f7fd0ca-db18-4ddc-a1ad-e982a1e53e84 35 fields · synced Jun 8, 2026