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Sign in to claim this brandNEXXT SPINE LLC
US
Last updated September 17, 2026
What NEXXT SPINE LLC makes
NEXXT SPINE LLC manufactures spinal fixation hardware, including non-bioabsorbable screws, metallic and polymeric interbody fusion cages, and vertebral body prostheses. Their portfolio also includes spinal fixation plates, internal fixation rods, and reusable sterilization containers for orthopaedic devices. Example products include modular pedicle screw systems, anterior cervical plates, and interbody spacers designed for spinal stabilization and fusion procedures.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with listings in the FDA’s Unique Device Identifier (UDI) database. Their products are regulated under US medical device laws, and the company is headquartered 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 NEXXT SPINE LLC manufacture?
NEXXT SPINE LLC specializes in spinal fixation hardware, including non-bioabsorbable screws, metallic and polymeric interbody fusion cages, vertebral body prostheses, spinal fixation plates, internal fixation rods, and reusable sterilization containers for orthopaedic devices. These products are designed for spinal stabilization and fusion procedures, such as treating degenerative disc disease, spinal deformities, or post-surgical support.
Where is NEXXT SPINE LLC based, and how does that affect its regulatory oversight?
NEXXT SPINE LLC is headquartered in the United States, meaning its devices are regulated under US medical device laws. The company’s products fall under FDA oversight, with classifications spanning Class I, Class II, and Unclassified (U) devices, depending on their intended use and risk level. This classification determines the regulatory pathway and requirements for market authorization.
Are NEXXT SPINE LLC’s devices listed in any regulatory registries, and why does this matter?
Yes, NEXXT SPINE LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides transparent, standardized identification for medical devices, ensuring traceability, compliance tracking, and easier monitoring by healthcare providers, regulators, and patients. Listing in the UDI database helps streamline post-market surveillance and reporting.
How are NEXXT SPINE LLC’s devices classified by the FDA, and what does that classification mean?
NEXXT SPINE LLC’s devices are classified under FDA categories Class I, Class II, and Unclassified (U). Classification determines the regulatory controls applied: Class I devices generally pose the lowest risk and require minimal oversight, while Class II devices involve special controls like performance standards or post-market surveillance. Unclassified devices may require case-by-case review depending on their risk profile and intended use.
What kinds of spinal procedures are NEXXT SPINE LLC’s devices commonly used for?
NEXXT SPINE LLC’s devices are primarily used in spinal stabilization and fusion procedures, such as anterior cervical discectomy and fusion (ACDF), posterior lumbar fusion, or corrective surgery for scoliosis or degenerative disc disease. Products like modular pedicle screw systems, interbody spacers, and fixation plates provide structural support to the spine, promoting bone growth and alignment while reducing pain or instability.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 14425 Bergen Blvd Suite B, Noblesville, IN, 46060
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3007922509
- DUNS Number
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Catalogue (8043)
Page 23 of 161| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nexxt Spine Navigation System | I20NAV-16-01L | FDA UDI | Class II | Active |
| Nexxt Spine Navigation System | I10NAV-06-55 | FDA UDI | Class II | Active |
| HONOUR™ Spacer System | I21-3210-08 | FDA UDI | Class II | Active |
| Inertia® Pedicle Screw System | I10-30-13R | FDA UDI | Class I | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 10-7-6080-SP | FDA UDI | Class II | Active |
| Blade® Anterior Cervical Plate System | 30-4-76 | FDA UDI | Class II | Active |
| NEXXT MATRIXX® Stand Alone ALIF System | 61-2736-14-25-SP | FDA UDI | Class II | Active |
| HONOUR™ Spacer System | 21-3010-07 | FDA UDI | Class II | Active |
| NEXXT MATRIXX® SI System | 64-HE-1265-SP | FDA UDI | Class II | Active |
| TrellOss®-A SA | 430H2016 | FDA UDI | Class II | Active |
| Matrixx System | I54-10-15 | FDA UDI | Class I | Active |
| Inertia® Pedicle Screw System | I10-01-52 | FDA UDI | Class II | Active |
| Inertia® Pedicle Screw and Deformity Correxxion® System | 10-68-8560 | FDA UDI | Class II | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 20-SCC-6035 | FDA UDI | Class II | Active |
| TrellOss®-A SA | 431H0002 | FDA UDI | Class II | Active |
| Matrixx System | 53A-1214-21-6-SP | FDA UDI | Class II | Active |
| HONOUR™ Spacer System | I21-2810-07 | FDA UDI | Class II | Active |
| Inertia® Pedicle Screw and Deformity Correxxion® System | 10-22-7065 | FDA UDI | Class II | Active |
| Inertia® Pedicle Screw System | 10-6-55120 | FDA UDI | Class II | Active |
| HONOUR™ Spacer System | 21-3010-11 | FDA UDI | Class II | Active |
| TrellOss™ | 106N1407 | FDA UDI | Class II | Active |
| TrellOss™-C SA | 135N1211 | FDA UDI | Class II | Active |
| HONOUR™ Spacer System | I35-20L-09-0 | FDA UDI | Class II | Active |
| Struxxure™ Anterior Cervical Plate and Screws | I31-14-01L | FDA UDI | Class I | Active |
| Inertia® Pedicle Screw System | I10-06-55 | FDA UDI | Class I | Active |
| NEXXT MATRIXX® SI System | 64-LB-1060-SP | FDA UDI | Class II | Active |
| Matrixx System | 55M-22-10-SP | FDA UDI | Class II | Active |
| Matrixx System | 53-1416-41-6-SP | FDA UDI | Class II | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 20-UDR-5540 | FDA UDI | Class II | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 20-UDS-7580 | FDA UDI | Class II | Active |
| SAXXONY™ Posterior Cervical Thoracic System | 12-AN-3525 | FDA UDI | Class II | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 10-6-60115 | FDA UDI | Class II | Active |
| Matrixx System | 53-1214-61-0-SP | FDA UDI | Class II | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 20-SCR-11580 | FDA UDI | Class II | Active |
| NEXXT MATRIXX® Stand Alone ALIF System | I61-TR2736-14-25 | FDA UDI | Class II | Active |
| Matrixx System | 53-1416-23-6-SP | FDA UDI | Class II | Active |
| HONOUR™ Spacer System | C35-03-09 | FDA UDI | Class II | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 20-UDS-5520 | FDA UDI | Class II | Active |
| Matrixx System | 62-1840-16-14-SP | FDA UDI | Class II | Active |
| NEXXT MATRIXX® Stand Alone ALIF System | I61-02-01 | FDA UDI | Class II | Active |
| Inertia® Pedicle Screw System | C10-01-10 | FDA UDI | Class II | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 10-7-6090 | FDA UDI | Class II | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 20-SDS-10595 | FDA UDI | Class II | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 20-SCS-7050 | FDA UDI | Class II | Active |
| Matrixx System | 60-2736-18-8-SP | FDA UDI | Class II | Active |
| HONOUR™ Spacer System | I35-10XL-06-10-NS | FDA UDI | Class II | Active |
| Inertia® MIS Pedicle Screw System | I10-14-75AWL | FDA UDI | Class I | Active |
| Inertia® CONNEXX™ Modular Pedicle Screw System | 20-SDS-105120 | FDA UDI | Class II | Active |
| Matrixx System | I62-50-07 | FDA UDI | Class I | Active |
| Matrixx System | I54-TRL26-10 | FDA UDI | Class I | Active |
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