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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 intraoperative surgical angle measurement tool
De Novo Number DEN230012
Device Name Ruthless Spine RJB
Requester
ruthless, llc dba ruthless spine
1438 arrow highway ste f/g
irwindale,  CA  91706
Contact renita howard
Regulation Number888.4560
Classification Product Code
QWL  
Date Received02/16/2023
Decision Date 07/14/2023
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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