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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 orthopedic strain sensor
De Novo Number DEN180012
Device Name LOADPRO™ Intraoperative Rod Strain Sensor
Requester
intellirod spine, inc.
554f white pond drive
akron,  OH  44320
Contact richard r. navarro
Regulation Number888.3090
Classification Product Code
QFP  
Date Received03/14/2018
Decision Date 03/28/2019
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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