# Nexxt Spine, LLC

- Location (FDA's records): Noblesville, IN
- FDA decisions: 24 (2009–2025): 24 510(k) clearances
- Names in FDA's records: Nexxt Spine, LLC (22); Nexxt Spine (2)
- Product codes: MAX (4), KWQ (3), NKB (3), OVE (2), ODP (2), MNH (2), MNI (2), OLO (1), NKG (1), OUR (1), PLR (1), MRW (1)
- 510(k) review time since 2016: median 53 days, against 90 for FDA's reviews in the same codes and years (11 of 16 faster)
- Predicates its devices cite: 90 (33 its own); citations of its devices by later devices: 71 (33 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- K2m, Inc.: 6 (https://510kreport.com/company/k2m)
- Medtronic Sofamor Danek USA, Inc.: 5 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Stryker Spine: 5 (https://510kreport.com/company/stryker-spine)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- Depuyacromed: 3 (https://510kreport.com/company/depuyacromed)
- SI-BONE, Inc.: 2 (https://510kreport.com/company/si-bone)
- Corelink, LLC: 2 (https://510kreport.com/company/corelink)

## Firms that cite its devices most
- Osseus Fusion Systems, LLC: 4 (https://510kreport.com/company/osseus-fusion-systems)
- Alphatec Spine, Inc.: 3 (https://510kreport.com/company/alphatec-spine)
- Vy Spine, LLC: 2 (https://510kreport.com/company/vy-spine)
- MiRus, LLC: 2 (https://510kreport.com/company/mirus)
- Spinevision S.A.: 2 (https://510kreport.com/company/spinevision)
- Nvision Biomedical Technologies, Inc.: 2 (https://510kreport.com/company/nvision-biomedical-technologies)
- Corelink, LLC: 2 (https://510kreport.com/company/corelink)
- Eminent Spine: 2 (https://510kreport.com/company/eminent-spine)

## Its most-cited devices
- K171140: Matrixx System (2017), cited by 14
- K120345: Honour Spacer System (2012), cited by 9
- K101278: Inertia Pedicle Screw System (2010), cited by 7
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), cited by 5
- K090984: Inertia Pedicle Screw System (2009), cited by 5
- K153453: Inertia Pedicle Screw and Deformity Correxxion System (2016), cited by 4

## Recent decisions
- K243838: NEXXT MATRIXX® SI System (Mar 14, 2025)
- K240690: STRUXXURE® MCS Anterior Cervical Plate System (Mar 22, 2024)
- K231799: INERTIA® CONNEXX™ Modular Pedicle Screw System (Jul 20, 2023)
- K221905: INERTIA CONNEXX Modular Pedicle Screw System (Jul 28, 2022)
- K220291: NEXXT SPINE NAVIGATION System (Mar 31, 2022)
- K202230: NEXXT MATRIXX Stand Alone ALIF System (Dec 15, 2020)
- K202192: STRUXXURE®-L and STRUXXURE®-A Plate System (Sep 17, 2020)
- K200969: NEXXT MATRIXX  System (May 21, 2020)

Source page: https://510kreport.com/company/nexxt-spine