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510(k) K152568

C-VBR by Cardinal Spine, LLC — Product Code PLR

K152568 is an FDA 510(k) premarket notification submitted by Cardinal Spine, LLC for the device "C-VBR". The FDA issued a decision of Substantially Equivalent on February 11, 2016. The device falls under product code PLR (Spinal Vertebral Body Replacement Device - Cervical), a Class II device regulated under 21 CFR 888.3060. Cardinal Spine, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2016
Date Received
September 9, 2015
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 Cardinal Spine, LLC

  • K142030 — STGC-LORDOTIC (January 23, 2015)
  • K121176 — STGC (August 17, 2012)
  • K100698 — STCC (March 14, 2011)

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)
  • K193412 — NEXXT MATRIXX System (February 24, 2020)
  • K190284 — Bengal Stackable Cage System (December 20, 2019)
  • K190426 — ALTA Anterior Cervical Corpectomy System (October 24, 2019)

FDA data resources