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FDA 510(k) Applications Submitted by Stephanie M. 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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