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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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