Company ยท US
Astura Medical
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 |
| NKB | Thoracolumbosacral Pedicle Screw System | 5 |
| OLO | Orthopedic Stereotaxic Instrument | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| NKG | Posterior Cervical Screw System | 1 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 1 |
| OUR | Sacroiliac Joint Fixation | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
| OWI | Bone Fixation Cerclage, Sublaminar | 1 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 1 |
| PML | Bone Cement, Posterior Screw Augmentation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 2026 | K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System Astura Medical | PML |
| Oct 21, 2025 | K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System Astura Medical | NKB |
| Jan 7, 2025 | K243259 | MASADA Modular Spinal Fixation System Astura Medical | NKB |
| Oct 17, 2024 | K240160 | EGPS Navigated Instruments Astura Medical | OLO |
| Mar 8, 2024 | K233359 | DOMINION Expandable Corpectomy System Astura Medical | MQP |
| Nov 16, 2023 | K231694 | MASADA Modular Spinal Fixation System Astura Medical | NKB |
| Oct 24, 2023 | K232211 | REUNION Sacroiliac Joint Fusion System Astura Medical | OUR |
| May 9, 2023 | K223335 | SIRION Lateral Lumbar Interbody System Astura Medical | MAX |
| May 4, 2023 | K222097 | OLYMPIC Deformity Band System Astura Medical | OWI |
| Jan 19, 2023 | K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion Astura Medical | OVD |
| Mar 30, 2022 | K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System Astura Medical | OVD |
| Jan 6, 2021 | K202495 | SIRION Lateral Lumbar Interbody Fusion Astura Medical, LLC | MAX |
| Oct 26, 2020 | K202065 | DOLOMITE Anterior Cervical Stabilization System Astura Medical, LLC | OVE |
| Apr 21, 2020 | K192492 | EL CAPITAN Anterior Lumber Interbody System Astura Medical, LLC | OVD |
| Apr 2, 2020 | K192006 | SIRION Lateral Lumbar Interbody System Astura Medical, LLC | MAX |
| Oct 24, 2019 | K190426 | ALTA Anterior Cervical Corpectomy System Astura Medical, LLC | PLR |
| May 3, 2019 | K182877 | HALF DOME Posterior Lumbar Interbody System Astura Medical, LLC | MAX |
| Jan 4, 2019 | K182982 | BridalVeil Navigated Instruments Astura Medical | OLO |
| Oct 18, 2018 | K182239 | OLYMPIC Posterior Spinal Fixation System Astura Medical, LLC | NKB |
| Jul 6, 2018 | K181139 | OLYMPIC Posterior Spinal Fixation System Astura Medical, LLC | NKB |
| Apr 27, 2018 | K172166 | OLYMPIC Navigated Instruments Astura Medical | OLO |
| Apr 18, 2018 | K172947 | HALF DOME Posterior Lumbar Interbody System Astura Medical | MAX |
| Feb 27, 2018 | K173324 | ALTA Anterior Cervical Interbody Spacer Astura Medical | ODP |
| Oct 2, 2017 | K171250 | BRIDALVEIL Occipital Cervical Thoracic System Astura Medical | NKG |
| May 3, 2017 | K163481 | HALF DOME Posterior Lumbar Interbody System Astura Medical | MAX |
| Aug 23, 2016 | K160702 | ZION Anterior Cervical Fixation System Astura Medical | KWQ |
| May 13, 2016 | K160154 | ALTA Anterior Cervical Interbody Spacer Astura Medical | ODP |
| Apr 8, 2016 | K153446 | OLYMPIC Posterior Spinal Fixation System Astura Medical | OSH |
| Jan 28, 2016 | K152512 | Half Dome Posterior Lumbar Interbody System Astura Medical | MAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||