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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
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