gudid Primary ID: 10-55-PR-100

Streamline TL Spinal Fixation System (UDI 10-55-PR-100)

Manufactured by Xtant Medical Holdings, Inc.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Streamline TL Spinal Fixation System (Model/Catalog Number: 10-55-PR-100) is a medical device manufactured by Xtant Medical Holdings, Inc.. This product is indexed under FDA Product Code / Category Classification NKB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 10-55-PR-100
Product Code / EMDN: NKB
Device Name: Rod, Pre-Bent 5.5mm X 100mm
Database Sync Date: 2026-08-09 09:02:16

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 Streamline TL Spinal Fixation System?

The registered manufacturer of record for Streamline TL Spinal Fixation System is Xtant Medical Holdings, Inc..

What is the Primary UDI-DI identifier for Streamline TL Spinal Fixation System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10-55-PR-100.

What classification code is assigned to this device?

This device is registered under product classification code NKB.

Similar Classification Devices (NKB)

Other Devices by Xtant Medical Holdings, Inc.

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