gudid Primary ID: 65-TC-T32-13-12L

Fortilink-TC IBF System (UDI 65-TC-T32-13-12L)

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 Fortilink-TC IBF System (Model/Catalog Number: 65-TC-T32-13-12L) is a medical device manufactured by Xtant Medical Holdings, Inc.. This product is indexed under FDA Product Code / Category Classification HWT within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 65-TC-T32-13-12L
Product Code / EMDN: HWT
Device Name: FORTILINK-TC TRIAL SPACER 1032-13-12L
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 Fortilink-TC IBF System?

The registered manufacturer of record for Fortilink-TC IBF System is Xtant Medical Holdings, Inc..

What is the Primary UDI-DI identifier for Fortilink-TC IBF System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 65-TC-T32-13-12L.

What classification code is assigned to this device?

This device is registered under product classification code HWT.

Similar Classification Devices (HWT)

Other Devices by Xtant Medical Holdings, Inc.

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