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510(k) K212126

MediExpand Cervical Expandable VBR System by Cmf Medicon Surgical, Inc. — Product Code PLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2022
Date Received
July 7, 2021
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 Cmf Medicon Surgical, Inc.

  • K241253 — Medicon Epiplating System (December 12, 2024)
  • K242764 — MediRod Pedicle Screw System (November 13, 2024)
  • K190349 — MediExpand TL Expandable VBR System (October 24, 2019)

Other clearances for product code PLR

  • 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)
  • K211320 — CAPRI Corpectomy Cage System (February 24, 2022)
  • K192145 — Galileo Vertebral Body Replacement Device (April 21, 2020)
  • K193412 — NEXXT MATRIXX System (February 24, 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)