FDA Registration Number: 3021680719

Last Validated: April 21, 2025

Status: Valid

Valid2025 U.S. FDA Medical Device Establishment Registration

QUALITEX INC.

Establishment Information

4185 E. Park 30 Drive
Columbia City IN, US

Official Correspondent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name Product Code Status Last Validated  
Orthopedic Manual Surgical Instrument LXH Valid April 20, 2025

Device Listing

Device Name

Orthopedic Manual Surgical Instrument

Product Code

LXH

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

Ball Level
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT Valid April 20, 2025

Device Listing

Device Name

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code

KTT

Company Function(s)

Contract Manufacturer

Proprietary Name(s)

External Frame Circular

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