enforcement Primary ID: Z-1131-2026

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm (UDI Z-1131-2026)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm (Model/Catalog Number: Unspecified) is a medical device manufactured by Tyber Medical. This product is indexed under FDA Product Code / Category Classification Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294; within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

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Technical Specifications

Model Number: N/A
Product Code / EMDN: Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;
Device Name: Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
Database Sync Date: 2026-08-09 10:06:32

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm?

The registered manufacturer of record for Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm is Tyber Medical.

What is the Primary UDI-DI identifier for Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-1131-2026.

What classification code is assigned to this device?

This device is registered under product classification code Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;.

Other Devices by Tyber Medical

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