FDA 510(k) Applications Submitted by KAREN E WARDEN

FDA 510(k) Number Submission Date Device Name Applicant
K100377 02/12/2010 DIAMONDBACK SPINAL SYSTEM EMINENT SPINE
K090387 02/17/2009 KAINOS+ SIGNUS MEDIZINTECHNIK GMBH
K090984 04/07/2009 INERTIA PEDICLE SCREW SYSTEM NEXXT SPINE LLC
K101278 05/06/2010 INERTIA PEDICLE SCREW SYSTEM NEXXT SPINE LLC
K071372 05/16/2007 MODIFICATION TO: INTERPLATE VBR SYSTEM RSB SPINE LLC.
K091926 06/30/2009 CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM CHOICE SPINE, LP
K092540 08/19/2009 C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER RSB SPINE LLC.
K093089 10/01/2009 MAGNUM NAIL ROBERT REID INC.
K070316 02/01/2007 INTERPLATE VBR SYSTEM RSB SPINE LLC.
K120345 02/03/2012 HONOUR SPACER SYSTEM NEXXT SPINE LLC
K100354 02/12/2010 PRIMAL OK INTERSPINOUS FUSION SYSTEM OSTEOMED L.P.
K140397 02/18/2014 PARALOCK PLATING SYSTEM / TUFFNEK SCREW PARAGON 28
K980852 03/05/1998 GII SPINAL FIXATION SYSTEM KAREN E. WARDEN, M.E.B.E.
K080815 03/24/2008 TOSCA II ANTERIOR CERVICAL PLATE SYSTEM SIGNUS MEDIZINTECHNIK GMBH
K071151 04/25/2007 TENSION BAND ANTERIOR SPINAL SYSTEM SPINAL INSTRUMENTATION SIMPLIFICATION SYSTEMS LLC
K081194 04/28/2008 INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) RSB SPINE LLC.
K021379 05/01/2002 SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 ORTHO TEC LLC
K081332 05/12/2008 ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM SIGNUS MEDIZINTECHNIK GMBH
K131372 05/13/2013 MOBIS II SIGNUS MEDIZINTECHNIK GMBH
K061401 05/19/2006 INTERPLATE VBR SYSTEM RSB SPINE LLC.
K141376 05/27/2014 INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS NEXXT SPINE LLC
K011807 06/11/2001 SCS CLARIS SPINAL SCREWS, TYPES V,G,E ORTHOTEC,LLC
K021919 06/11/2002 SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO ORTHOTEC,LLC
K012045 06/29/2001 HIGHGATE CURVED ROD SYSTEM HIGHGATE ORTHOPAEDICS
K091936 06/30/2009 BLADE ANTERIOR CERVICAL PLATE SYSTEM NEXXT MEDICAL INC
K092070 07/08/2009 INTERPLATE C RSB SPINE LLC.
K071922 07/12/2007 INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC RSB SPINE LLC.
K122317 08/01/2012 TETRIS II SIGNUS MEDIZINTECHNIK GMBH
K102438 08/26/2010 PRIMALOK FACET FIXATION SYSTEM OSTEOMED L.P.
K032752 09/05/2003 R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM R&B SURGICAL SOLUTIONS, LLC.
K032815 09/09/2003 PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM PRECISION SURGERY LIMITED
K102822 09/28/2010 IMPLANT-ONE SYSTEM CUSTOM DENTAL IMPLANTS INC
K082848 09/29/2008 NUBIC AND RABEA DEVICES SIGNUS MEDIZINTECHNIK GMBH
K133103 09/30/2013 AVERSION PEDICLE SCREW SYSTEM K7 LLC
K103068 10/18/2010 KING COBRA ANTERIOR CERVICAL PLATE EMINENT SPINE
K133402 11/06/2013 K2M MODULAR HOOKS K2M, INC.
K023983 12/02/2002 MODIFICATION TO HIGHGATE CURVED ROD SYSTEM HIGHGATE ORTHOPAEDICS
K093833 12/14/2009 KAPSS SPINAL SYSTEM ROBERT REID INC.
K073669 12/26/2007 ORIA NATURA SPACER CHOICE SPINE, LP
K103819 12/30/2010 PSL ANTERIOR CERVICAL PLATE SYSTEM PRECISION SURGERY LTD.
K073708 12/31/2007 FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM PRECISION SURGERY LTD.
K140280 02/04/2014 FORTICORE NANOVIS, LLC
K131417 05/16/2013 FACET FIXX NEXXT SPINE LLC
K113173 10/27/2011 NANOVIS SPINAL SYSTEM NANOVIS, LLC
K120074 01/10/2012 FOUNDATION SPINAL SYSTEM THE SKELETAL DESIGN PARTNERSHIP LTD.
K130504 02/27/2013 ASA ORAL APPLIANCES AMERICAN SLEEP ASSOCIATION
K111009 04/11/2011 ACRYLIC HERBST APPLIANCE EMBASSY DENTAL LABORATORY
K131292 05/06/2013 DEROYAL SPINE SPACER SYSTEM DEROYAL INDUSTRIES, INC.
K111792 06/27/2011 MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI SIGNUS MEDIZINTECHNIK GMBH
K111930 07/07/2011 ACKERMANN EUROPCLIP ACKERMANN INSTRUMENTE GMBH
K132310 07/25/2013 ASCOT BACKROADS CONSULTING, INC.
K122664 08/31/2012 ZUGA DENTAL IMPLANT SYSTEM ZUGA MEDICAL, INC.
K133126 09/30/2013 K7 LUMBAR SPACERS K7 LLC
K113126 10/24/2011 ACRYLIC HERBST APPLIANCE GERGENS ORTHODONTIC LAB
K123758 12/07/2012 TASMIN R SIGNUS MEDIZINTECHNIK GMBH
K123969 12/26/2012 XIPHOS DIFUSION TECHNOLOGIES
K124027 12/28/2012 MONSTER SCREW SYSTEM APOGEE ORTHOSOLUTIONS
K103838 12/30/2010 FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM PRECISION SURGERY LTD.


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