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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name limb and joint salvage device with coating for bacteria reduction
De Novo Number DEN210058
Device Name ELEOSx™ Limb Salvage System
Requester
onkos surgical
77 east halsey rd
parsippany,  NJ  07054
Contact matthew (matt) vernak
Regulation Number888.3900
Classification Product Code
QZZ  
Date Received12/30/2021
Decision Date 04/05/2024
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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