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510(k) K193412

NEXXT MATRIXX System by Nexxt Spine, LLC — Product Code PLR

K193412 is an FDA 510(k) premarket notification submitted by Nexxt Spine, LLC for the device "NEXXT MATRIXX System". The FDA issued a decision of Substantially Equivalent on February 24, 2020. The device falls under product code PLR (Spinal Vertebral Body Replacement Device - Cervical), a Class II device regulated under 21 CFR 888.3060. Nexxt Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2020
Date Received
December 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device - Cervical
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Vertebral body replacement in the cervical spine.

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)
  • K193370 — Nexxt Matrixx System (January 21, 2020)

Other clearances for product code PLR

  • K252822 — Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant (July 15, 2026)
  • K252560 — Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (November 10, 2025)
  • K232481 — RIGEL™ 3DR Anterior Cervical Corpectomy System (October 13, 2023)
  • K221542 — Galileo Vertebral Body Replacement Device (January 13, 2023)
  • K212126 — MediExpand Cervical Expandable VBR System (April 4, 2022)
  • K211320 — CAPRI Corpectomy Cage System (February 24, 2022)
  • K192145 — Galileo Vertebral Body Replacement Device (April 21, 2020)
  • K190284 — Bengal Stackable Cage System (December 20, 2019)
  • K190426 — ALTA Anterior Cervical Corpectomy System (October 24, 2019)
  • K191778 — Omnia Medical VBR (August 28, 2019)

FDA data resources