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FDA 510(k) Applications Submitted by Astura Medical, LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190426
02/22/2019
ALTA Anterior Cervical Corpectomy System
Astura Medical, LLC
K181139
04/30/2018
OLYMPIC Posterior Spinal Fixation System
Astura Medical, LLC
K202065
07/27/2020
DOLOMITE Anterior Cervical Stabilization System
Astura Medical, LLC
K192006
07/29/2019
SIRION Lateral Lumbar Interbody System
Astura Medical, LLC
K182239
08/20/2018
OLYMPIC Posterior Spinal Fixation System
Astura Medical, LLC
K202495
08/31/2020
SIRION Lateral Lumbar Interbody Fusion
Astura Medical, LLC
K192492
09/11/2019
EL CAPITAN Anterior Lumber Interbody System
Astura Medical, LLC
K182877
10/15/2018
HALF DOME Posterior Lumbar Interbody System
Astura Medical, LLC
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