FDA 510(k) Applications Submitted by Kristen Allen

FDA 510(k) Number Submission Date Device Name Applicant
K160291 02/03/2016 Optimus ALIF System Amendia, Inc.
K191791 07/03/2019 TranS1 Interbody Fusion System TranS1
K152455 08/28/2015 Amendia Cervical Plate System Amendia, Inc
K192792 09/30/2019 TranS1 AxiaLIF Plus System TranS1
K152920 10/02/2015 Savannah-T« Pedicle Screw System AMENDIA, INC.
K152972 10/08/2015 Amendia Stand-Alone Cervical System AMENDIA, INC.
K153152 11/02/2015 Syzygy Stabilization System AMENDIA, INC.
K133743 12/09/2013 BAXANO SURGICAL MIS SPINAL SYSTEM BAXANO SURGICAL, INC.


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