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FDA 510(k) Applications Submitted by VIVIAN KELLY MS, RAC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100409
02/16/2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
BIOMET SPINE (AKA EBI, LLC)
K082187
08/04/2008
BIOMET ANTERIOR LUMBAR PLATE
EBI, L.P.
K123451
11/09/2012
POLARIS SPINAL SYSTEM - BALLISTA II RODS
BIOMET SPINE (AKA EBI, LLC)
K132373
07/30/2013
BIOMET ACCESS SYSTEM
BIOMET SPINE (AKA EBI, LLC)
K123549
11/19/2012
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
BIOMET SPINE (AKA EBI, LLC)
K133746
12/09/2013
POLARIS SPINAL SYSTEM
BIOMET SPINE (AKA EBI, LLC)
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