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Medfix International, LLC

United States·US-MF-000053473

Last updated September 17, 2026

About

See the full selection of orthopedic, neurosurgical, and spine instruments at Medfix. If you have questions give us a call at 520-398-5467.

From the manufacturer's own website. Source

What Medfix International, LLC makes

Medfix International, LLC manufactures reusable surgical instruments for orthopedic, neurosurgical, and spinal procedures, including retraction systems (blades and mounting frames), bone curettes, spinal rongeurs, bone levers/elevators, and surgical handles. Their product line also includes sterilization/disinfection containers designed for medical device reprocessing. These instruments are intended for use in operating rooms and procedural settings requiring precision retraction or bone manipulation.

The company’s devices fall under Class I regulatory classification in the U.S., with all products listed in the FDA’s Unique Device Identifier (UDI) database. Medfix International, LLC is headquartered in the United States, adhering to domestic medical device regulations.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Medfix International, LLC manufacture?

Medfix International, LLC specializes in reusable surgical instruments primarily used in orthopedic, neurosurgical, and spinal procedures. Their product line includes surgical retractors (both blades and mounting frames), bone curettes, spinal rongeurs, bone levers/elevators, nerve/vessel retractors, surgical instrument handles, and sterilization/disinfection containers. These devices are designed for precision retraction, bone manipulation, and safe reprocessing in operating rooms and procedural settings.

Where is Medfix International, LLC based, and what regulatory framework does it follow?

Medfix International, LLC is headquartered in the United States. Since their devices fall under Class I regulatory classification in the U.S., they must comply with FDA requirements for medical devices, including registration, listing, and adherence to general controls. Class I devices are typically considered low-risk, but they still require compliance with manufacturing, labeling, and post-market surveillance standards.

Are Medfix International, LLC’s devices listed in any regulatory registries?

Yes, Medfix International, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory oversight and improving patient safety by enabling better device traceability.

How are Medfix International, LLC’s devices classified under U.S. regulations?

All of Medfix International, LLC’s devices are classified as Class I under U.S. regulations. This classification is based on their intended use and risk profile—these instruments are reusable surgical tools designed for controlled, low-risk applications in orthopedic, neurosurgical, and spinal procedures. Class I devices generally require compliance with basic FDA regulations, including proper labeling, manufacturing controls, and registration.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
5620 , North Kolb Road, Tucson, United States
LinkedIn
—
Facebook
—
Phone
+1(520) 398-5467
PRRC Contact
Jay Samaha
EUDAMED SRN
US-MF-000053473
FDA FEI Number
3006765019
DUNS Number
—

Catalogue (1044)

Page 7 of 21
DeviceModel / ReferenceRegistriesClassStatus
Medfix MF14-2309
FDA UDI
Class IActive
Medfix MF232-2612B
FDA UDI
Class IActive
Medfix MF-7470
FDA UDI
Class IActive
Medfix MF137-7202B
FDA UDI
Class IActive
Medfix MF-H2
FDA UDI
Class IActive
Medfix MF-2365SLS
FDA UDI
Class IActive
Medfix MF-7462
FDA UDI
Class IActive
Medfix MF-0087
FDA UDI
Class IActive
Medfix MF-22110TTB
FDA UDI
Class IActive
Medfix MF-2360SS
FDA UDI
Class IActive
Medfix MF260-1004
FDA UDI
Class IActive
Medfix MF676-8502
FDA UDI
Class IActive
Medfix MFP-2350SS
FDA UDI
Class IActive
Medfix MF95-2737
FDA UDI
Class IActive
Medfix MF-9036
FDA UDI
Class IActive
Medfix MF249-7105TCC
FDA UDI
Class IActive
Medfix MF367-2601B
FDA UDI
Class IActive
Medfix MF-24100TTB
FDA UDI
Class IActive
Medfix MF-2260TB
FDA UDI
Class IActive
Medfix MF-22100TTB
FDA UDI
Class IActive
Medfix MF-24120TTS
FDA UDI
Class IActive
Medfix MF-2365NS
FDA UDI
Class IActive
Medfix MF235-7201T
FDA UDI
Class IActive
Medfix MF-0056
FDA UDI
Class IActive
Medfix MF367-3601B
FDA UDI
Class IActive
Medfix MF-2355LS
FDA UDI
Class IActive
Medfix MF15-2309
FDA UDI
Class IActive
Medfix MF-1008
FDA UDI
Class IActive
Medfix MF232-2482B
FDA UDI
Class IActive
Medfix MF-1840TTS
FDA UDI
Class IActive
Medfix MF-26120TS
FDA UDI
Class IActive
Medfix MF-7468
FDA UDI
Class IActive
Medfix MF-2330NS
FDA UDI
Class IActive
Medfix MF-1690TB
FDA UDI
Class IActive
Medfix MF267-2603B
FDA UDI
Class IActive
Medfix MF110-1880-INSERT
FDA UDI
Class IActive
Medfix MF-8034
FDA UDI
Class IActive
Medfix MF-2760
FDA UDI
Class IActive
Medfix MF-9002
FDA UDI
Class IActive
Medfix MF235-7205T
FDA UDI
Class IActive
Medfix MF112-0161
FDA UDI
Class IActive
Medfix MF01852
FDA UDI
Class IActive
Medfix MF-2345FR
FDA UDI
Class IActive
Medfix MF-2270TTS
FDA UDI
Class IActive
Medfix MF-1750
FDA UDI
Class IActive
Medfix MF750-3025
FDA UDI
Class IActive
Medfix MF01862
FDA UDI
Class IActive
Medfix MF-9004
FDA UDI
Class IActive
Medfix MF-7486S
FDA UDI
Class IActive
Medfix MF676-7001B
FDA UDI
Class IActive

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