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Sign in to claim this brandSURGIX MEDICAL LLC
US
Last updated September 17, 2026
What SURGIX MEDICAL LLC makes
Surgix Medical LLC manufactures reusable orthopaedic and spinal surgical instruments, including rongeurs for joint and limb procedures, bone curettes, and retractors. Their portfolio also includes general-purpose surgical scissors, suction system catheters, and soft-tissue manipulation forceps designed for reusable clinical use.
The company’s devices are classified under FDA’s Class I and Class II regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
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 Surgix Medical LLC manufacture?
Surgix Medical LLC specializes in reusable surgical instruments primarily for orthopaedic and spinal procedures. Their portfolio includes orthopaedic joint/limb rongeurs, spinal rongeurs, bone curettes, surgical retractors, general-purpose surgical scissors, suction system catheters, and soft-tissue manipulation forceps (both tweezers-like and scissors-like). These tools are designed for repeated clinical use in operating rooms.
Where is Surgix Medical LLC based?
Surgix Medical LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device regulations.
Are Surgix Medical LLC’s devices listed in any regulatory registries?
Yes, Surgix Medical LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices through standardized identifiers, ensuring traceability and compliance with U.S. regulatory requirements.
How are Surgix Medical LLC’s devices classified under FDA regulations?
Surgix Medical LLC’s devices fall under two FDA classification categories: Class I and Class II. Class I generally includes low-risk devices requiring general controls, while Class II devices involve additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s purpose, intended use, and potential risks.
Why do some of Surgix Medical LLC’s devices fall under different FDA classes?
The FDA categorizes devices based on their risk levels and intended use. For example, reusable surgical scissors (often Class I) may carry lower risk compared to specialized orthopaedic rongeurs (potentially Class II) due to factors like complexity, surgical precision requirements, or potential impact on patient safety. Classification ensures appropriate regulatory oversight tailored to the device’s purpose.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 22317 GOSLING RD, Spring, TX, 77389
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3012995405
- DUNS Number
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Catalogue (3991)
Page 32 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gen2 | G2N99401 | FDA UDI | Class I | Active |
| Gen2 | G2N28608 | FDA UDI | Class II | Active |
| Gen2 | G2N87137 | FDA UDI | Class I | Active |
| Gen2 | G2O2009 | FDA UDI | Class I | Active |
| Gen2 | G2C62411 | FDA UDI | Class I | Active |
| Gen2 | G2C62265 | FDA UDI | Class I | Active |
| Gen2 | G2N63054B | FDA UDI | Class II | Active |
| Gen2 | G2N87441 | FDA UDI | Class I | Active |
| Gen2 | G2N62007 | FDA UDI | Class II | Active |
| Gen2 | G2N49362 | FDA UDI | Class I | Active |
| Gen2 | G2N76302 | FDA UDI | Class II | Active |
| Gen2 | G2E901161 | FDA UDI | Class I | Active |
| Gen2 | G2N64752B | FDA UDI | Class II | Active |
| Gen2 | G2N87401 | FDA UDI | Class I | Active |
| Gen2 | G2N7003 | FDA UDI | Class I | Active |
| Gen2 | G2E2590 | FDA UDI | Class I | Active |
| Gen2 | G2N87423 | FDA UDI | Class I | Active |
| Gen2 | G2E17516 | FDA UDI | Class I | Active |
| Gen2 | G2N63844 | FDA UDI | Class II | Active |
| Gen2 | G2N87414 | FDA UDI | Class I | Active |
| Gen2 | G2N63835G | FDA UDI | Class II | Active |
| Gen2 | G2G10010 | FDA UDI | Class I | Active |
| Gen2 | G2N72622 | FDA UDI | Class II | Active |
| Gen2 | G2N28221 | FDA UDI | Class II | Active |
| Gen2 | G2N63152 | FDA UDI | Class II | Active |
| Gen2 | G2N63760 | FDA UDI | Class II | Active |
| Gen2 | G2N63846 | FDA UDI | Class II | Active |
| Gen2 | G2E901132 | FDA UDI | Class I | Active |
| Gen2 | G2N63844B | FDA UDI | Class II | Active |
| Gen2 | G2N71711 | FDA UDI | Class II | Active |
| Gen2 | G2O2004 | FDA UDI | Class I | Active |
| Gen2 | G2N63153G | FDA UDI | Class II | Active |
| Gen2 | G2N87466 | FDA UDI | Class I | Active |
| Gen2 | G2N28204 | FDA UDI | Class II | Active |
| Gen2 | G2N4745 | FDA UDI | Class II | Active |
| Gen2 | G2NHX28075 | FDA UDI | Class II | Active |
| FusionMAX | 33501-26-001 | FDA UDI | Class I | Active |
| Gen2 | G2N63723G | FDA UDI | Class II | Active |
| Gen2 | G2N63825G | FDA UDI | Class II | Active |
| FusionMAX | 33501-21-003 | FDA UDI | Class I | Active |
| Gen2 | G2N4732 | FDA UDI | Class II | Active |
| Gen2 | G2OB1609 | FDA UDI | Class I | Active |
| Gen2 | G2C62405 | FDA UDI | Class I | Active |
| Gen2 | G2N87201 | FDA UDI | Class I | Active |
| Gen2 | G2N63734 | FDA UDI | Class II | Active |
| Gen2 | G2G14250 | FDA UDI | Class I | Active |
| Gen2 | G2N2533 | FDA UDI | Class II | Active |
| Gen2 | G2C62276 | FDA UDI | Class II | Active |
| Gen2 | G2G21260 | FDA UDI | Class I | Active |
| Gen2 | G2N28902 | FDA UDI | Class II | Active |
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