FDA 510(k) Applications Submitted by Parker Kelch

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
K222097 07/18/2022 OLYMPIC Deformity Band System Astura Medical
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
K222554 08/23/2022 EL CAPITAN Anterior Lumbar Interbody Fusion Astura Medical
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
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


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