NEXXT MATRIXX Stand Alone ALIF System
FDA 510(k) K202230 · Nexxt Spine, LLC
510(k) numberK202230
Submission
- Device name
- NEXXT MATRIXX Stand Alone ALIF System
- Applicant
- Nexxt Spine, LLC
Noblesville, IN, US - Received
- August 7, 2020
- Decision date
- December 15, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
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| K243838 | NEXXT MATRIXX® SI SystemOUR · Traditional | 03/14/2025SE |
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| K221905 | INERTIA CONNEXX Modular Pedicle Screw SystemNKB · Special | 07/28/2022SE |
| K220291 | NEXXT SPINE NAVIGATION SystemOLO · Traditional | 03/31/2022SE |
| 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 |
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Questions and answers
When was NEXXT MATRIXX Stand Alone ALIF System cleared by the FDA?
NEXXT MATRIXX Stand Alone ALIF System (K202230) received a 510(k) decision of Substantially Equivalent on December 15, 2020, 130 days after the submission was received.
What is the product code of K202230?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.