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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 hydrogel spacer
De Novo Number DEN140030
Device Name SpaceOAR System
Requester
augmenix, inc.
204 second ave., lower level
waltham,  MA  02451
Contact noel rolon
Regulation Number892.5725
Classification Product Code
OVB  
Date Received10/01/2014
Decision Date 04/01/2015
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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