FDA 510(k) Applications Submitted by David Kirschman
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140079 |
01/13/2014 |
SILEX SACROILIAC JOINT FUSION 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. |
| K120832 |
03/19/2012 |
FORTEX PEDICLE SCREW SYSTEM |
X-SPINE SYSTEMS, INC |
| K150834 |
03/30/2015 |
Atrax Anterior Cervical Plating System |
X-Spine Systems, Inc |
| K131350 |
05/10/2013 |
CALIX LUMBAR SPINAL IMPLANT 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. |
| K112036 |
07/18/2011 |
CALIX PC SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC |
| K122163 |
07/20/2012 |
CERTEX SPINAL IMPLANT 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. |
| K112592 |
09/07/2011 |
AXLE PEEK INTERSPINOUS FUSION SYSTEM |
X-SPINE SYSTEMS, INC |
| K072943 |
10/17/2007 |
BUTREX BUTTRESS PLATING SYSTEM |
X-SPINE SYSTEMS, INC. |
| K203189 |
10/27/2020 |
AEROCURE-MD |
Aerobiotix, Inc. |
| K083637 |
12/09/2008 |
CALIX SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC. |
| K123932 |
12/20/2012 |
ZYGAFIX SPINAL FACET SCREW SYSTEM |
X-SPINE SYSTEMS, INC |
| K133947 |
12/23/2013 |
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM |
X-SPINE SYSTEMS, INC |
| K130438 |
02/21/2013 |
AXLE INTERSPINOUS FUSION SYSTEM |
X-SPINE SYSTEMS, INC. |
| K133094 |
09/30/2013 |
CERTEX OCT SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC |
| K123702 |
12/03/2012 |
SILEX SACROILIAC JOINT FUSION SYSTEM |
X-SPINE SYSTEMS, INC. |
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