FDA 510(k) Applications Submitted by Parker Kelch

FDA 510(k) Number Submission Date Device Name Applicant
K240160 01/19/2024 EGPS Navigated Instruments Astura Medical
K190426 02/22/2019 ALTA Anterior Cervical Corpectomy System Astura Medical, LLC
K181139 04/30/2018 OLYMPIC Posterior Spinal Fixation System Astura Medical, LLC
K231694 06/09/2023 MASADA Modular Spinal Fixation System Astura Medical
K222097 07/18/2022 OLYMPIC Deformity Band System Astura Medical
K232211 07/26/2023 REUNION Sacroiliac Joint Fusion 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
K233359 09/29/2023 DOMINION Expandable Corpectomy System Astura Medical
K182877 10/15/2018 HALF DOME Posterior Lumbar Interbody System Astura Medical, LLC
K243259 10/15/2024 MASADA Modular Spinal Fixation System 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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact