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510(k) K193412

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

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

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  • K231799 — INERTIA® CONNEXX™ Modular Pedicle Screw System (July 20, 2023)
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  • 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

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  • 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)
  • K191423 — Normandy VBR System (August 6, 2019)