FDA 510(k) Applications Submitted by Richard Jansen
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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 |
| K233966 |
12/15/2023 |
Anterior Spine Truss System-Stand Alone (ASTS-SA) |
4WEB Medical, Inc. |
| 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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