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510(k) K142030

STGC-LORDOTIC by Cardinal Spine, LLC — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2015
Date Received
July 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Cardinal Spine, LLC

  • K152568 — C-VBR (February 11, 2016)
  • K121176 — STGC (August 17, 2012)
  • K100698 — STCC (March 14, 2011)

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