ACS (UDI FDTK07AH)

Manufactured by AMERICAN CONTRACT SYSTEMS, INC.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ACS (Model/Catalog Number: FDTK07AH) is a medical device manufactured by AMERICAN CONTRACT SYSTEMS, INC.. This product is indexed under FDA Product Code / Category Classification OJH within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: FDTK07AH
Product Code / EMDN: OJH
Device Name: TOTAL KNEE REPLACEMENT
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 ACS?

The registered manufacturer of record for ACS is AMERICAN CONTRACT SYSTEMS, INC..

What is the Primary UDI-DI identifier for ACS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FDTK07AH.

What classification code is assigned to this device?

This device is registered under product classification code OJH.

Similar Classification Devices (OJH)

Other Devices by AMERICAN CONTRACT SYSTEMS, INC.

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