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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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