FDA 510(k) Applications Submitted by RICH JANSEN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110067 |
01/10/2011 |
LP CAGE |
MEDYSSEY CO., LTD. |
| K130066 |
01/10/2013 |
SPECTRUM SPINE SPINOUS PROCESS DEVICE |
SPECTRUM SPINE IP HOLDINGS, LLC |
| K120292 |
01/31/2012 |
CAPLOX II PEDICLE SCREW SYSTEM |
CAPTIVA SPINE, INC |
| K130402 |
02/19/2013 |
SPIDER SYSTEM KOLIBRI CEMENT NEEDLE |
SINTEA PLUSTEK, LLC |
| K140787 |
03/31/2014 |
PLS (POSTERIOR LUMBAR SYSTEM) |
SINTEA PLUSTEK, LLC |
| K131538 |
05/29/2013 |
CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM |
CAPTIVA SPINE |
| K111626 |
06/10/2011 |
ENDOSKELETON(R) TAS |
TITAN SPINE, LLC |
| K131878 |
06/24/2013 |
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM |
MEDYSSEY USA, INC. |
| K141695 |
06/24/2014 |
ACROSSPINE PEDICLE SCREW SYSTEM |
ARTHRO-DIF |
| K141850 |
07/09/2014 |
FLOSPINE PEDICLE SCREW SYSTEM |
FLOSPINE |
| K102067 |
07/23/2010 |
ENDOSKELETON TO |
TITAN SPINE, LLC |
| K122332 |
08/02/2012 |
TOWERLOX PEDICLE SCREW SYSTEM |
CAPTIVA SPINE |
| K142112 |
08/04/2014 |
4WEB SPINAL IMPLANT PRODUCTS |
4WEB, INC. |
| K112429 |
08/23/2011 |
GIZA(R) VERTEBRAL BODY REPLACEMENT |
EDEN SPINE, LLC |
| K112700 |
09/16/2011 |
FRONTIER SADL INTERBODY FUSION DEVICE |
FRONTIER MEDICAL DEVICES, INC. |
| K132907 |
09/17/2013 |
PLIF LITE AND TLIF LITE |
SINTEA PLUSTEK |
| K122956 |
09/25/2012 |
FUSELOX LUMBAR INTERBODY FUSION DEVICE |
CAPTIVA SPINE |
| K133036 |
09/26/2013 |
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS |
AMENDIA INC. |
| K113011 |
10/11/2011 |
SPARTAN S3 FACET SYSTEM |
AMENDIA, INC. |
| K140564 |
03/05/2014 |
BN LUMBAR CAGE SYSTEM |
MEDYSSEY USA, INC. |
| K130185 |
01/25/2013 |
4WEB OSTEOTOMY BONE WEDGE |
4-WEB, INC. |
| K121741 |
06/13/2012 |
4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) |
4-WEB, INC. |
| K112316 |
08/11/2011 |
4-WEB ALIF SPINAL TRUSS SYSTEM (STS) |
4-WEB, INC. |
| K133459 |
11/12/2013 |
ELITE IBF |
INNOVA SPINAL TECHNOLOGIES, LLC |
| K133063 |
09/27/2013 |
SANTIS PEDICLE SCREW SYSTEM |
LANTERNA MEDICAL TECHNOLOGIES |
| K133066 |
09/27/2013 |
SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM |
SPINESELECT, LLC |
| K080058 |
01/09/2008 |
TURBO PRIME IBD SYSTEM |
SPINE SELECT, LLC |
| K070281 |
01/29/2007 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
| K061041 |
04/14/2006 |
US SPINE FACET FIXATION SYSTEM |
US SPINE |
| K091122 |
04/17/2009 |
DIANA FUSION CAGE |
SIGNUS MEDICAL |
| K081108 |
04/18/2008 |
MONOPOLY PEDICLE SCREW SYSTEM |
SIGNUS MEDICAL LLC. |
| K081240 |
05/01/2008 |
TIGER DISCECTOMY DEVICE |
SPINAL DEVICES, LLC |
| K091619 |
06/03/2009 |
ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) |
ANGLEFIX |
| K081883 |
07/02/2008 |
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM |
US SPINE |
| K072116 |
08/01/2007 |
SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM |
NEUROSPINE INNOVATIONS AND SOLUTIONS |
| K092568 |
08/20/2009 |
SPARTAN S3 FACET SYSTEM |
AMENDIA, INC. |
| K062785 |
09/18/2006 |
LTD POLYAXIAL FIXATION SYSTEM |
US SPINE |
| K092901 |
09/21/2009 |
EPICAGE INTERBODY FUSION DEVICE |
R TREE INNOVATIONS |
| K083167 |
10/27/2008 |
PHENIX CERVICAL INTERBODY DEVICE |
SPINAL DEVICES, LLC |
| K083714 |
12/15/2008 |
ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) |
TITAN SPINE, LLC |
| K083894 |
12/29/2008 |
ALIF SPINAL TRUSS INTERBODY FUSION DEVICE |
4-WEB SPINE, LLC |
| K081296 |
05/07/2008 |
PREFERENCE PEDICLE SCREW SYSTEM |
US SPINE |
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