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X-Spine Systems, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories8
Latest FDA decision2018-05-17
TypeNumberDevice NameCodeDateActions
510(k) K173832 InTice™-C Porous Ti Cervical Interbody SystemODP2018-05-17 View
510(k) K180153 X-spine Cortical Bone Screw SystemNKB2018-03-15 View
510(k) K170119 Calix Lumbar Spinal Implant SystemMAX2017-09-29 View
510(k) K171567 IRIX-A Lumbar Integrated Fusion SystemOVD2017-08-28 View
510(k) K171075 Calix-C Cervical Interbody SpacerODP2017-08-01 View
510(k) K170224 Spider Cervical Plating SystemKWQ2017-07-06 View
510(k) K170530 Butrex Lumbar Buttress Plating SystemKWQ2017-03-22 View
510(k) K160959 Xsert Lumbar Expandable Interbody SystemMAX2016-11-17 View
510(k) K162944 Irix-C Cervical Integrated Fusion SystemOVE2016-11-07 View
510(k) K160428 Certex Spinal Fixation SystemNKG2016-05-05 View
510(k) K160114 Xspan Laminoplasty Fixation SystemNQW2016-03-15 View