FDA 510(k) Applications Submitted by Stephanie Fitts

FDA 510(k) Number Submission Date Device Name Applicant
K180163 01/19/2018 TransEnterix Senhance Surgical System TransEnterix, Inc.
K110807 03/23/2011 ABG II MONOLITHIC HIP STEM STRYKER CORP.
K171120 04/14/2017 Senhance Surgical Robotic System TransEnterix, Inc.
K102282 08/12/2010 THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
K112455 08/25/2011 AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
K103010 10/12/2010 STRYKER PATIENT SPECIFIC POLYMER IMPLANT HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
K122308 08/01/2012 AXSOS DISTAL LATERAL FEMUR TS LONG PLATES HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
K182421 09/05/2018 Senhance Ultrasonic System TransEnterix, Inc.


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