NEXXT MATRIXX System
FDA 510(k) K193412 · Nexxt Spine, LLC
510(k) numberK193412
Submission
- Device name
- NEXXT MATRIXX System
- Applicant
- Nexxt Spine, LLC
Noblesville, IN, US - Received
- December 9, 2019
- Decision date
- February 24, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLR – Spinal Vertebral Body Replacement Device - Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Vertebral body replacement in the cervical spine.
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|---|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | Atlas Spine, Inc. | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | Atlas Spine, Inc. | 11/10/2025SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | MiRus, LLC | 10/13/2023SE |
| K221542 | Galileo Vertebral Body Replacement DevicePLR · Special | Bright Spine | 01/13/2023SE |
| K212126 | MediExpand Cervical Expandable VBR SystemPLR · Traditional | Cmf Medicon Surgical, Inc. | 04/04/2022SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | K2m, Inc. | 02/24/2022SE |
| K192145 | Galileo Vertebral Body Replacement DevicePLR · Traditional | Bright Spine | 04/21/2020SE |
| K190284 | Bengal Stackable Cage SystemPLR · Traditional | Medos International SARL | 12/20/2019SE |
| K190426 | ALTA Anterior Cervical Corpectomy SystemPLR · Traditional | Astura Medical, LLC | 10/24/2019SE |
| K191778 | Omnia Medical VBRPLR · Special | Omnia Medical, LLC | 08/28/2019SE |
More from Omnia Medical, LLC
| 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 |
| K193370 | Nexxt Matrixx SystemMAX · Special | 01/21/2020SE |
Questions and answers
When was NEXXT MATRIXX System cleared by the FDA?
NEXXT MATRIXX System (K193412) received a 510(k) decision of Substantially Equivalent on February 24, 2020, 77 days after the submission was received.
What is the product code of K193412?
The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.