eudamed_udi Primary ID: 10888857063419

ALEUTIAN® Interbody Systems (UDI 10888857063419)

Manufactured by K2M, Inc.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ALEUTIAN® Interbody Systems (Model/Catalog Number: 3201-90793) is a medical device manufactured by K2M, Inc.. This product is indexed under FDA Product Code / Category Classification L091199 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1307-2022 View Full Alert →

Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments....

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Technical Specifications

Model Number: 3201-90793
Product Code / EMDN: L091199
Device Name: Aleutian: Lordotic Angled Trial
Database Sync Date: 2026-08-09 16:29:11

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 ALEUTIAN® Interbody Systems?

The registered manufacturer of record for ALEUTIAN® Interbody Systems is K2M, Inc..

What is the Primary UDI-DI identifier for ALEUTIAN® Interbody Systems?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10888857063419.

What classification code is assigned to this device?

This device is registered under product classification code L091199.

Similar Classification Devices (L091199)

Other Devices by K2M, Inc.

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