Spinenet, LLC

Medical device manufacturer in Winter Park, FL.

2510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K200170SpineNet SSP SystemKWQ · Traditional 02/05/2020SE
K110733Daytona Anterior Cervical CageODP · Traditional 08/25/2011SE

Recalls

RecallProductInitiated
Z-2103-2013 Class IISpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona…The recall decision has been made because because it has recently been determined that the instructions for… 02/05/2013Terminated
Z-2107-2013 Class IISpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration…SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval. 02/04/2013Terminated