eudamed_udi
Primary ID: 00858704006138
KneeAlign 2 (UDI 00858704006138)
Manufactured by OrthAlign, Inc
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for KneeAlign 2 - Primary ID 00858704006138
Device Regulatory Overview
The KneeAlign 2 (Model/Catalog Number: 401582) is a medical device manufactured by OrthAlign, Inc. This product is indexed under FDA Product Code / Category Classification L0908 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 401582
- Product Code / EMDN
- L0908
- Device Name
- Ankle Tube
- Database Sync Date
- 2026-08-09 16:29:45
Full Regulatory Attributes
đź”’ Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of KneeAlign 2?
The registered manufacturer of record for KneeAlign 2 is OrthAlign, Inc.
What is the Primary UDI-DI identifier for KneeAlign 2?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00858704006138.
What classification code is assigned to this device?
This device is registered under product classification code L0908.
Similar Classification Devices (L0908)
Other Devices by OrthAlign, Inc
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