Nexxt Matrixx System
FDA 510(k) K193370 · Nexxt Spine, LLC
510(k) numberK193370
Submission
- Device name
- Nexxt Matrixx System
- Applicant
- Nexxt Spine, LLC
Noblesville, IN, US - Received
- December 5, 2019
- Decision date
- January 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243838 | NEXXT MATRIXX® SI SystemOUR · Traditional | 03/14/2025SE |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate SystemKWQ · Special | 03/22/2024SE |
| K231799 | INERTIA® CONNEXX Modular Pedicle Screw SystemNKB · Special | 07/20/2023SE |
| K221905 | INERTIA CONNEXX Modular Pedicle Screw SystemNKB · Special | 07/28/2022SE |
| K220291 | NEXXT SPINE NAVIGATION SystemOLO · Traditional | 03/31/2022SE |
| K202230 | NEXXT MATRIXX Stand Alone ALIF SystemOVD · Traditional | 12/15/2020SE |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate SystemKWQ · Traditional | 09/17/2020SE |
| K200969 | NEXXT MATRIXX SystemMAX · Special | 05/21/2020SE |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemOVE · Special | 03/23/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | 02/24/2020SE |
Questions and answers
When was Nexxt Matrixx System cleared by the FDA?
Nexxt Matrixx System (K193370) received a 510(k) decision of Substantially Equivalent on January 21, 2020, 47 days after the submission was received.
What is the product code of K193370?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.