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FDA 510(k) Applications Submitted by Shikha Gola
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100220
01/26/2010
POLARIS SPINAL SYSTEM
EBI, L.P.
K100805
03/22/2010
GALLERY LAMINOPLASTY FIXATION SYSTEM
BIOMET SPINE (AKA EBI, LLC)
K130900
04/01/2013
EVICEL APPLICATION DEVICE
ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS
K211493
05/13/2021
Monarch Platform
Auris Health, Inc.
K092078
07/09/2009
OPTILOCK PERIARTICULAR PLATING
BIOMET TRAUMA
K092670
08/31/2009
BIODRIVE MICRO SCREW SYSTEM
EBI,LLC D/B/A BIOMET TRAUMA
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