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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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