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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 intervertebral body graft containment device
De Novo Number DEN200010
Device Name Spineology Interbody Fusion System
Requester
spineology, inc.
7800 3rd street north, suite 600
saint paul,  MN  55128
Contact andrew adams
Regulation Number888.3085
Classification Product Code
OQB  
Date Received02/19/2020
Decision Date 09/18/2020
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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