Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021680719

FEI Number

3021680719

Entity Name

QUALITEX NE LLC

City/State/Country

Columbia City, IN, US

Establishment Address

4185 E. Park 30 Dr, Columbia City, IN 46725, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Qualitex NE LLC (Owner Number: 10095312)

Owner / Operator Contact Address

4185 E. Park 30 Dr, Columbia City, IN 46725, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2026-02-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Qualitex NE LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20

Similar Registrations

Registration Number	Establishment Name	Location
3044090645	MEDUSA ORTHOPEDICS, LLC	Fleetwood, PA, US
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3015869121	Jabil Switzerland Manufacturing GmbH (Raron)	Raron Valais, CH
1043653	ONYX MEDICAL LLC	MEMPHIS, TN, US
3009826895	MEDICAL DEVICE AND IMPLANTS LLC	Lancaster, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021680719. Last updated year: 2026. Please use registration number 3021680719 when referencing this establishment in official correspondence.