Home / 510(k) Clearances / K190284

510(k) K190284

Bengal Stackable Cage System by Medos International SARL — Product Code PLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2019
Date Received
February 11, 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 Medos International SARL

  • K253249 — TriALTIS™ Spine System (October 21, 2025)
  • K243249 — TriALTIS™ Spine System (January 17, 2025)
  • K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (September 16, 2024)
  • K242042 — TriALTIS™ Spine System (September 9, 2024)
  • K233684 — TriALTIS™ Spine System (December 12, 2023)
  • K233366 — SYMPHONY OCT System (November 9, 2023)
  • K232492 — 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomp (October 6, 2023)
  • K231479 — TriALTIS Spine System (September 22, 2023)
  • K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications (February 10, 2023)
  • K223108 — TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear (January 19, 2023)

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)
  • 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)
  • K193412 — NEXXT MATRIXX System (February 24, 2020)
  • K190426 — ALTA Anterior Cervical Corpectomy System (October 24, 2019)
  • K191778 — Omnia Medical VBR (August 28, 2019)
  • K191423 — Normandy VBR System (August 6, 2019)