Home / Companies / Paradigm Spine, LLC

Paradigm Spine, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K213493Fortilink with TiPlus TechnologyJanuary 27, 2022
K201453Fortilink Cages with TiPlus TechnologyOctober 7, 2020
K201704CoFix SystemAugust 4, 2020
K153302coflex-IFSeptember 8, 2016
K120491DSS STABILIZATION SYSTEM-RIGIDMay 9, 2012
K112595COFLEX-FFebruary 13, 2012
K113625DSS STABILIZATION SYSTEMJanuary 10, 2012
K093438PARADIGM INTERSPINOUS FUSION PLATEOctober 6, 2010
K101083DSS STABILIZATION SYSTEMJuly 2, 2010
K091944MODIFICATION TO: DSS STABILIZATION SYSTEMAugust 3, 2009
K090099DSS STABILIZATION SYSTEMJune 19, 2009
K090408MODIFICATION TO: DSS STABILIZATION SYSTEMMarch 20, 2009
K080241DDS STABILIZATION SYSTEMNovember 28, 2008
K071668ORTHOBIOM SPINAL SYSTEMJuly 2, 2008
K080963DSS STABILIZATION SYSTEMMay 2, 2008
K072969DSSJanuary 24, 2008