FDA 510(k) Applications Submitted by KAREN E WARDEN PHD

FDA 510(k) Number Submission Date Device Name Applicant
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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