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510(k) K190025

EVOL® -SI Joint Fusion System by Cutting Edge Spine, LLC — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2019
Date Received
January 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sacroiliac Joint Fixation
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

sacroiliac joint fusion

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  • K180891 — EVOL Spinal Interbody System, EVOS Lumbar Interbody System (May 4, 2018)
  • K150321 — EVOS Lumbar Interbody System (July 13, 2015)
  • K102957 — CUTTING EDGE SPINE INTERBODY FUSION DEVICE (April 28, 2011)

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