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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
- Website
- www.medfix.com
- —
- —
- [email protected]
- Phone
- +1(520) 398-5467
- PRRC Contact
- Jay Samaha
- EUDAMED SRN
- US-MF-000053473
- FDA FEI Number
- 3006765019
- DUNS Number
- —
Catalogue (1044)
Page 16 of 21| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Medfix | MFL-2345AS | FDA UDI | Class I | Active |
| Medfix | MF051-601 | FDA UDI | Class I | Active |
| Medfix | MF-2030TTB | FDA UDI | Class I | Active |
| Medfix | MF-0111S | FDA UDI | Class I | Active |
| Medfix | MF051-605 | FDA UDI | Class I | Active |
| Medfix | MF112-0164 | FDA UDI | Class I | Active |
| Medfix | MF-9019 | FDA UDI | Class I | Active |
| Medfix | MF-1850TS | FDA UDI | Class I | Active |
| Medfix | MF100-3382 | FDA UDI | Class I | Active |
| Medfix | MF-2090 | FDA UDI | Class I | Active |
| Medfix | MF100-3377 | FDA UDI | Class I | Active |
| Medfix | MF-1465BS | FDA UDI | Class I | Active |
| Medfix | MF676-8506B | FDA UDI | Class I | Active |
| Medfix | MF-2355SS | FDA UDI | Class I | Active |
| Medfix | MF-4022 | FDA UDI | Class I | Active |
| Medfix | MFP-2375LS | FDA UDI | Class I | Active |
| Medfix | MF-9016 | FDA UDI | Class I | Active |
| Medfix | MF750-3008 | FDA UDI | Class I | Active |
| Medfix | MF367-2604B | FDA UDI | Class I | Active |
| Medfix | MFP-2375SS | FDA UDI | Class I | Active |
| Medfix | MF-1811 | FDA UDI | Class I | Active |
| Medfix | MF267-2604B | FDA UDI | Class I | Active |
| Medfix | MFP-1430BS | FDA UDI | Class I | Active |
| Medfix | MF-2440TTB | FDA UDI | Class I | Active |
| Medfix | MF-7492 | FDA UDI | Class I | Active |
| Medfix | MF306-4307 | FDA UDI | Class I | Active |
| Medfix | MF213-2003 | FDA UDI | Class I | Active |
| Medfix | MF110-1899-INSERT | FDA UDI | Class I | Active |
| Medfix | MFP-2340LS | FDA UDI | Class I | Active |
| Medfix | MF676-7002B | FDA UDI | Class I | Active |
| Medfix | MF232-2607 | FDA UDI | Class I | Active |
| Medfix | MFP-2335LS | FDA UDI | Class I | Active |
| Medfix | MF-1630TTS | FDA UDI | Class I | Active |
| Medfix | MF-2370BS | FDA UDI | Class I | Active |
| Medfix | MF-8028 | FDA UDI | Class I | Active |
| Medfix | MF-MH4 | FDA UDI | Class I | Active |
| Medfix | MF-8023 | FDA UDI | Class I | Active |
| Medfix | MF-2490TTS | FDA UDI | Class I | Active |
| Medfix | MF-1812 | FDA UDI | Class I | Active |
| Medfix | MF-2350LLS | FDA UDI | Class I | Active |
| Medfix | MF-22120SB | FDA UDI | Class I | Active |
| Medfix | MF-1690TS | FDA UDI | Class I | Active |
| Medfix | MF-2330SLS | FDA UDI | Class I | Active |
| Medfix | MF-20120TTS | FDA UDI | Class I | Active |
| Medfix | MF232-2347B | FDA UDI | Class I | Active |
| Medfix | MF210-0300 | FDA UDI | Class I | Active |
| Medfix | MF-22100TB | FDA UDI | Class I | Active |
| Medfix | MF-1740 | FDA UDI | Class I | Active |
| Medfix | MF-2365BLS | FDA UDI | Class I | Active |
| Medfix | MF235-7203T | FDA UDI | Class I | Active |
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