Astura Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
29
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemJanuary 22, 2026
K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemOctober 21, 2025
K243259MASADA Modular Spinal Fixation SystemJanuary 7, 2025
K240160EGPS Navigated InstrumentsOctober 17, 2024
K233359DOMINION Expandable Corpectomy SystemMarch 8, 2024
K231694MASADA Modular Spinal Fixation SystemNovember 16, 2023
K232211REUNION Sacroiliac Joint Fusion SystemOctober 24, 2023
K223335SIRION Lateral Lumbar Interbody SystemMay 9, 2023
K222097OLYMPIC Deformity Band SystemMay 4, 2023
K222554EL CAPITAN Anterior Lumbar Interbody FusionJanuary 19, 2023
K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemMarch 30, 2022
K202495SIRION Lateral Lumbar Interbody FusionJanuary 6, 2021
K202065DOLOMITE Anterior Cervical Stabilization SystemOctober 26, 2020
K192492EL CAPITAN Anterior Lumber Interbody SystemApril 21, 2020
K192006SIRION Lateral Lumbar Interbody SystemApril 2, 2020
K190426ALTA Anterior Cervical Corpectomy SystemOctober 24, 2019
K182877HALF DOME Posterior Lumbar Interbody SystemMay 3, 2019
K182982BridalVeil Navigated InstrumentsJanuary 4, 2019
K182239OLYMPIC Posterior Spinal Fixation SystemOctober 18, 2018
K181139OLYMPIC Posterior Spinal Fixation SystemJuly 6, 2018