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Sign in to claim this brandXenix Medical
US
Last updated September 17, 2026
What Xenix Medical makes
Xenix Medical manufactures spinal implants and fixation devices, including metallic interbody fusion cages for spinal procedures, sacroiliac joint fixation systems, and bone-screw connectors for internal spinal stabilization. Their portfolio also includes reusable orthopaedic implant inserters/extractors, surgical instrument racks, and internal orthopaedic distractors for surgical applications.
The company’s devices are classified under FDA’s Class I and Class II categories 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 Xenix Medical primarily manufacture?
Xenix Medical specializes in spinal implants and fixation devices. Their portfolio includes metallic spinal interbody fusion cages for fusing vertebrae, sacroiliac joint fixation systems to stabilize the SI joint, and bone-screw connectors for internal spinal stabilization. They also produce reusable orthopaedic tools like implant inserters/extractors and surgical instrument racks, as well as internal orthopaedic distractors for surgical procedures.
Where is Xenix Medical based, and what does that mean for their regulatory oversight?
Xenix Medical is based in the United States, which means their devices are subject to FDA regulations. The FDA classifies their products as either Class I (generally low-risk) or Class II (moderate-risk), requiring compliance with specific controls depending on the device type. Their devices are also listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory transparency.
Which regulatory registries or databases list Xenix Medical’s devices?
Xenix Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a standardized identifier for tracking, reporting, and compliance purposes, helping healthcare providers and regulators verify device details and regulatory status.
How are Xenix Medical’s devices classified under FDA regulations?
Xenix Medical’s devices fall into two FDA classification categories: Class I (for lower-risk items like surgical instrument racks) and Class II (for moderate-risk products such as spinal implants and fixation systems). Classification determines the regulatory controls applied—Class II devices require pre-market notifications (510(k)) or premarket approvals (PMA) depending on the specific risks, while Class I devices may only need general controls unless exempt.
What does it mean for a device to be listed in the FDA’s UDI database?
Listing in the FDA’s Unique Device Identifier (UDI) database means each of Xenix Medical’s devices has a unique, standardized code (like a barcode or serial number) that includes critical information such as the manufacturer, device type, and model. This system improves patient safety, streamlines reporting of adverse events, and ensures accurate tracking of devices throughout their lifecycle, from production to use in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 149 W Michigan St, Orlando, FL, 32806
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3012429289
- DUNS Number
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Catalogue (933)
Page 4 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| neoWave C | 20-RAT-5205 | FDA UDI | Class I | Active |
| NeoFuse Ti3D PLIF/TLIF | C3012-15 | FDA UDI | Class II | Unknown |
| NeoFuse HA Enhanced PLIF/TLIF | A2412-07 | FDA UDI | Class II | Unknown |
| neoWave C | 20-TFT-7308 | FDA UDI | Class I | Active |
| Xenix Medical Sacroiliac Fixation System | SS1-A3-000020 | FDA UDI | Class II | Active |
| SOLACE Sacroiliac Fixation System | SS1-A1-000040 | FDA UDI | Class II | Active |
| RIVA Posterior Fixation System | FG1-45-402400 | FDA UDI | Class II | Active |
| SOLACE Sacroiliac Fixation System | SS1-A1-000093 | FDA UDI | Class II | Active |
| NeoFuse Ti3D PLIF/TLIF | C3010-11 | FDA UDI | Class II | Unknown |
| RIVA Posterior Fixation System | FG1-45-400400 | FDA UDI | Class II | Active |
| neoWave C | 20-CFX-3211 | FDA UDI | Class II | Active |
| neoWave C | 20-CFN-5205 | FDA UDI | Class II | Active |
| neoWave C | 20-TFX-7306 | FDA UDI | Class I | Active |
| NeoFuse HA Enhanced PLIF/TLIF | A2012-07 | FDA UDI | Class II | Unknown |
| SOLACE Sacroiliac Fixation System | SS1-A2-000221 | FDA UDI | Class II | Active |
| neoWave C | 20-CFN-9406 | FDA UDI | Class II | Active |
| neoWave C | 20-TFN-5206 | FDA UDI | Class I | Active |
| neoWave LS | 23-K01-0209 | FDA UDI | Class I | Active |
| neoWave C | 20-TFN-3211 | FDA UDI | Class I | Active |
| Ti3D CERVICAL | B263-10 | FDA UDI | Class II | Active |
| neoWave LS | 23-LCT-2208 | FDA UDI | Class II | Active |
| neoWave LS | 23-LCX-2815 | FDA UDI | Class II | Active |
| neoWave C | 20-CFN-9410 | FDA UDI | Class II | Active |
| neoWave C | 20-CFX-3208 | FDA UDI | Class II | Active |
| Ti3D CERVICAL | C1614-10 | FDA UDI | Class II | Active |
| Ti3D CERVICAL | B221-09 | FDA UDI | Class II | Active |
| neoWave C | 20-TFN-3209 | FDA UDI | Class I | Active |
| Ti3D CERVICAL | B263-07 | FDA UDI | Class II | Active |
| neoWave C | 20-CFX-7309 | FDA UDI | Class II | Active |
| Ti3D CERVICAL | B04-01 | FDA UDI | Class I | Active |
| NeoFuse Ti3D PLIF/TLIF | C2012-09 | FDA UDI | Class II | Unknown |
| SOLACE Sacroiliac Fixation System | SS1-A2-000030 | FDA UDI | Class II | Active |
| neoWave C | 20-CFN-9407 | FDA UDI | Class II | Active |
| SOLACE Sacroiliac Fixation System | SS1-A2-000216 | FDA UDI | Class II | Active |
| neoWave C | 20-CAT-5211 | FDA UDI | Class II | Active |
| RIVA Posterior Fixation System | FG1-45-220060 | FDA UDI | Class II | Active |
| neoWave C | 20-CFT-9405 | FDA UDI | Class II | Active |
| neoWave C | 20-CFN-6405 | FDA UDI | Class II | Active |
| RIVA Posterior Fixation System | FG1-32-075040 | FDA UDI | Class II | Active |
| RIVA Posterior Fixation System | FG1-32-065040 | FDA UDI | Class II | Active |
| neoWave C | 20-TFX-3208 | FDA UDI | Class I | Active |
| neoWave C | 20-CFX-5207 | FDA UDI | Class II | Active |
| neoWave LS | 23-K01-0308 | FDA UDI | Class I | Active |
| NeoFuse HA Enhanced PLIF/TLIF | A3012-15 | FDA UDI | Class II | Unknown |
| Xenix Medical Sacroiliac Fixation System | SS1-A1-100006 | FDA UDI | Class II | Active |
| RIVA Posterior Fixation System | FG1-B0-001100 | FDA UDI | Class I | Active |
| Xenix Medical Universal Handle | UN1-H0-122002 | FDA UDI | Class I | Active |
| RIVA Posterior Fixation System | FG1-15-010090 | FDA UDI | Class II | Active |
| neoWave C | 20-CFN-5206 | FDA UDI | Class II | Active |
| neoWave C | 20-CFN-3208 | FDA UDI | Class II | Active |
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