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Astura Medical, LLC

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories5
Latest FDA decision2021-01-06
TypeNumberDevice NameCodeDateActions
510(k) K202495 SIRION Lateral Lumbar Interbody FusionMAX2021-01-06 View
510(k) K202065 DOLOMITE Anterior Cervical Stabilization SystemOVE2020-10-26 View
510(k) K192492 EL CAPITAN Anterior Lumber Interbody SystemOVD2020-04-21 View
510(k) K192006 SIRION Lateral Lumbar Interbody SystemMAX2020-04-02 View
510(k) K190426 ALTA Anterior Cervical Corpectomy SystemPLR2019-10-24 View
510(k) K182877 HALF DOME Posterior Lumbar Interbody SystemMAX2019-05-03 View
510(k) K182239 OLYMPIC Posterior Spinal Fixation SystemNKB2018-10-18 View
510(k) K181139 OLYMPIC Posterior Spinal Fixation SystemNKB2018-07-06 View