FDA 510(k) Applications Submitted by Astura Medical

FDA 510(k) Number Submission Date Device Name Applicant
K222097 07/18/2022 OLYMPIC Deformity Band System Astura Medical
K222554 08/23/2022 EL CAPITAN Anterior Lumbar Interbody Fusion Astura Medical
K182982 10/29/2018 BridalVeil Navigated Instruments Astura Medical
K223335 11/01/2022 SIRION Lateral Lumbar Interbody System Astura Medical
K214047 12/27/2021 EL CAPITAN Anterior Lumbar Interbody Fusion System Astura Medical
K152512 09/02/2015 Half Dome Posterior Lumbar Interbody System Astura Medical
K172947 09/26/2017 HALF DOME Posterior Lumbar Interbody System Astura Medical
K173324 10/20/2017 ALTA Anterior Cervical Interbody Spacer Astura Medical
K160154 01/20/2016 ALTA Anterior Cervical Interbody Spacer Astura Medical
K160702 03/14/2016 ZION Anterior Cervical Fixation System Astura Medical
K171250 04/28/2017 BRIDALVEIL Occipital Cervical Thoracic System Astura Medical
K172166 07/18/2017 OLYMPIC Navigated Instruments Astura Medical
K153446 11/27/2015 OLYMPIC Posterior Spinal Fixation System Astura Medical
K163481 12/12/2016 HALF DOME Posterior Lumbar Interbody System Astura Medical


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