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FDA 510(k) Applications Submitted by RICHARD JANSEN, PHARM. D.
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
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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