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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