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. |
|
|