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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K232790
Device Name KONG®-TL VBR System and KONG® C VBR System
Applicant
icotec AG
Industriestrasse 12
9450 Alstaetten (SG),  CH
Applicant Contact Marina Hess
Correspondent
MCRA, LLC
803 7th Street NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3060
Classification Product Code
MQP  
Subsequent Product Codes
NKB   PLR   PML  
Date Received09/11/2023
Decision Date 04/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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