gudid Primary ID: 08-SDF-4013

Ocata Anterior Cervical System (UDI 08-SDF-4013)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Ocata Anterior Cervical System (Model/Catalog Number: 08-SDF-4013) is a medical device manufactured by Kalitec Direct LLC. This product is indexed under FDA Product Code / Category Classification KWQ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 08-SDF-4013
Product Code / EMDN: KWQ
Device Name: Screw, Self Drilling, Fixed, 4.0 x 13mm
Database Sync Date: 2026-08-09 09:06:20

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 Ocata Anterior Cervical System?

The registered manufacturer of record for Ocata Anterior Cervical System is Kalitec Direct LLC.

What is the Primary UDI-DI identifier for Ocata Anterior Cervical System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08-SDF-4013.

What classification code is assigned to this device?

This device is registered under product classification code KWQ.

Similar Classification Devices (KWQ)

Other Devices by Kalitec Direct LLC

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