gudid Primary ID: 6977-901

CART, AXIS COMPONENT (UDI 6977-901)

Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The CART, AXIS COMPONENT (Model/Catalog Number: 6977-901) is a medical device manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.. This product is indexed under FDA Product Code / Category Classification JEA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 6977-901
Product Code / EMDN: JEA
Device Name
Database Sync Date: 2026-08-09 09:13:56

Full Regulatory Attributes

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{
    "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 CART, AXIS COMPONENT?

The registered manufacturer of record for CART, AXIS COMPONENT is MIZUHO ORTHOPEDIC SYSTEMS, INC..

What is the Primary UDI-DI identifier for CART, AXIS COMPONENT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 6977-901.

What classification code is assigned to this device?

This device is registered under product classification code JEA.

Similar Classification Devices (JEA)

Other Devices by MIZUHO ORTHOPEDIC SYSTEMS, INC.

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