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510(k) K171140

Matrixx System by Nexxt Spine, LLC — Product Code ODP

K171140 is an FDA 510(k) premarket notification submitted by Nexxt Spine, LLC for the device "Matrixx System". The FDA issued a decision of Substantially Equivalent on August 22, 2017. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), 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
August 22, 2017
Date Received
April 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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)
  • K202230 — NEXXT MATRIXX Stand Alone ALIF System (December 15, 2020)
  • 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)

Other clearances for product code ODP

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources