FDA 510(k) Applications Submitted by MARY STANNERS

FDA 510(k) Number Submission Date Device Name Applicant
K090425 02/19/2009 GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM ALPHATEC SPINE, INC.
K200410 02/19/2020 Reconnaissance PV .018 OTW Digital IVUS Catheter Philips Image Guided Therapy Corporation
K150442 02/20/2015 Volcano Visions PV .018 Digital IVUS Catheter Volcano Corporation
K080699 03/12/2008 NOVEL SPINAL SPACER SYSTEM ALPHATEC SPINE, INC.
K090782 03/23/2009 NOVEL ALIF SPINAL SPACER SYSTEM ALPHATEC SPINE, INC.
K081158 04/23/2008 ZODIC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K071890 07/09/2007 ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC.
K072081 07/30/2007 ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM ALPHATEC SPINE, INC.
K102402 08/24/2010 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM ALPHATEC SPINE, INC.
K162418 08/30/2016 Pioneer Plus Catheter PHILIPS VOLCANO
K152829 09/29/2015 Visions PV.014P RX Digital IVUS Catheter Volcano Corporation


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