FDA 510(k) Applications Submitted by X-spine Systems, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K170119 01/13/2017 Calix Lumbar Spinal Implant System X-Spine Systems, Inc.
K180153 01/19/2018 X-spine Cortical Bone Screw System X-spine Systems, Inc.
K173832 12/18/2017 InTiceÖ-C Porous Ti Cervical Interbody System X-Spine Systems, Inc.
K100154 01/20/2010 FIXCET SPINAL FACET SCREW SYSTEM X-SPINE SYSTEMS, INC.
K090224 01/30/2009 FORTEX PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC.
K160428 02/16/2016 Certex Spinal Fixation System X-spine Systems, Inc.
K101471 05/27/2010 AXLE INTERSPINOUS FUSION SYSTEM X-SPINE SYSTEMS, INC.
K131951 06/27/2013 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM X-SPINE SYSTEMS, INC.
K152132 07/31/2015 X-spine Pedicle Screw System X-spine Systems, Inc.
K092360 08/04/2009 ACP4 SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC.
K072282 08/16/2007 CAPLESS LI PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC.
K052292 08/23/2005 SPIDER CERVICAL PLATING (SCP) SYSTEM X-SPINE SYSTEMS, INC.
K072943 10/17/2007 BUTREX BUTTRESS PLATING SYSTEM X-SPINE SYSTEMS, INC.
K083637 12/09/2008 CALIX SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC.
K130438 02/21/2013 AXLE INTERSPINOUS FUSION SYSTEM X-SPINE SYSTEMS, INC.
K123702 12/03/2012 SILEX SACROILIAC JOINT FUSION SYSTEM X-SPINE SYSTEMS, INC.
K052847 10/07/2005 CAPLESS PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC.
K160114 01/19/2016 Xspan Laminoplasty Fixation System X-SPINE SYSTEMS, INC.
K170224 01/25/2017 Spider Cervical Plating System X-SPINE SYSTEMS, INC.
K170530 02/22/2017 Butrex Lumbar Buttress Plating System X-Spine Systems, Inc.
K160959 04/05/2016 Xsert Lumbar Expandable Interbody System X-SPINE SYSTEMS, INC.
K171075 04/11/2017 Calix-C Cervical Interbody Spacer X-Spine Systems, Inc.
K171567 05/30/2017 IRIX-A Lumbar Integrated Fusion System X-Spine Systems, Inc.
K162944 10/21/2016 Irix-C Cervical Integrated Fusion System X-SPINE SYSTEMS, INC.


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