gudid Primary ID: FG1-16-240085

RIVA Pedicle Screw System (UDI FG1-16-240085)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The RIVA Pedicle Screw System (Model/Catalog Number: FG1-16-240085) is a medical device manufactured by XENIX MEDICAL LLC. This product is indexed under FDA Product Code / Category Classification NKB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: FG1-16-240085
Product Code / EMDN: NKB
Device Name: Z-ROD, 6.0mm x 85mm
Database Sync Date: 2026-08-09 09:27:03

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 RIVA Pedicle Screw System?

The registered manufacturer of record for RIVA Pedicle Screw System is XENIX MEDICAL LLC.

What is the Primary UDI-DI identifier for RIVA Pedicle Screw System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FG1-16-240085.

What classification code is assigned to this device?

This device is registered under product classification code NKB.

Similar Classification Devices (NKB)

Other Devices by XENIX MEDICAL LLC

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