Nexxt Spine LLC
Noblesville, IN, US
NEXXT SPINE LLC appears in FDA device records in Noblesville, IN. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Nexxt Spine LLC between 2009 and 2025. The busiest year on record is 2020, with 7. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 7 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243838 | NEXXT MATRIXX® SI System | OUR | Substantially Equivalent | |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K231799 | INERTIA® CONNEXX™ Modular Pedicle Screw System | NKB | Substantially Equivalent | |
| K221905 | INERTIA CONNEXX Modular Pedicle Screw System | NKB | Substantially Equivalent | |
| K220291 | NEXXT SPINE NAVIGATION System | OLO | Substantially Equivalent | |
| K202230 | NEXXT MATRIXX Stand Alone ALIF System | OVD | Substantially Equivalent | |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate System | KWQ | Substantially Equivalent | |
| K200969 | NEXXT MATRIXX System | MAX | Substantially Equivalent | |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | OVE | Substantially Equivalent | |
| K193412 | NEXXT MATRIXX System | PLR | Substantially Equivalent | |
| K193370 | Nexxt Matrixx System | MAX | Substantially Equivalent | |
| K192687 | TrellOss™-L MPF | MAX | Substantially Equivalent | |
| K191408 | Nexxt Matrixx System | MAX | Substantially Equivalent | |
| K190546 | NEXXT MATRIXX Stand Alone Cervical System | OVE | Substantially Equivalent | |
| K182508 | Saxxony™ Posterior Cervical Thoracic System | NKG | Substantially Equivalent | |
| K171140 | Matrixx System | ODP | Substantially Equivalent | |
| K153453 | Inertia Pedicle Screw and Deformity Correxxion System | NKB | Substantially Equivalent | |
| K141376 | INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS | MNH | Substantially Equivalent | |
| K133475 | STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS | KWQ | Substantially Equivalent | |
| K132412 | INERTIA MIS PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | |
| K131417 | FACET FIXX | MRW | Substantially Equivalent | |
| K120345 | HONOUR SPACER SYSTEM | ODP | Substantially Equivalent | |
| K101278 | INERTIA PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | |
| K090984 | INERTIA PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007922509 | 3007922509 | NEXXT SPINE LLC | 14425 Bergen Blvd Suite B, Noblesville, IN 46060 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- NKGPosterior Cervical Screw System
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- OURSacroiliac Joint Fixation
- HWCScrew, Fixation, Bone
- MQPSpinal Vertebral Body Replacement Device
- PLRSpinal Vertebral Body Replacement Device - Cervical
- MRWSystem, Facet Screw Spinal Device
- HXGTamp
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain