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510(k) K200235

KONG-TL VBR System, KONG-C VBR System by Icotec AG — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2020
Date Received
January 30, 2020
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

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