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510(k) K202230

NEXXT MATRIXX Stand Alone ALIF System by Nexxt Spine, LLC — Product Code OVD

K202230 is an FDA 510(k) premarket notification submitted by Nexxt Spine, LLC for the device "NEXXT MATRIXX Stand Alone ALIF System". The FDA issued a decision of Substantially Equivalent on December 15, 2020. The device falls under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar), a Class II device regulated under 21 CFR 888.3080. Nexxt Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2020
Date Received
August 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

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 clearances by Nexxt Spine, LLC

  • K243838 — NEXXT MATRIXX® SI System (March 14, 2025)
  • K240690 — STRUXXURE® MCS Anterior Cervical Plate System (March 22, 2024)
  • K231799 — INERTIA® CONNEXX™ Modular Pedicle Screw System (July 20, 2023)
  • K221905 — INERTIA CONNEXX Modular Pedicle Screw System (July 28, 2022)
  • K220291 — NEXXT SPINE NAVIGATION System (March 31, 2022)
  • K202192 — STRUXXURE®-L and STRUXXURE®-A Plate System (September 17, 2020)
  • K200969 — NEXXT MATRIXX System (May 21, 2020)
  • K200543 — NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (March 23, 2020)
  • K193412 — NEXXT MATRIXX System (February 24, 2020)
  • K193370 — Nexxt Matrixx System (January 21, 2020)

Other clearances for product code OVD

  • K262025 — Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis (September 11, 2026)
  • K261408 — SABER-XA System (August 3, 2026)
  • K261809 — Interwedge® Standalone Lateral (July 31, 2026)
  • K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lum (July 15, 2026)
  • K260810 — Anteralign LS coverplate (June 10, 2026)
  • K254202 — MectaLIF 3D Metal Anterior (May 5, 2026)
  • K253401 — SCRIPT™ Implant System (April 29, 2026)
  • K253559 — Ventana™ A Anterior Lumbar Interbody System (February 25, 2026)
  • K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
  • K251575 — IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interb (September 3, 2025)

FDA data resources