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510(k) K221542

Galileo Vertebral Body Replacement Device by Bright Spine — Product Code PLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2023
Date Received
May 27, 2022
Clearance Type
Special
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 Bright Spine

  • K192145 — Galileo Vertebral Body Replacement Device (April 21, 2020)
  • K102449 — BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM (February 11, 2011)

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)
  • 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)
  • 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)