Astura Medical
Irving, TX, US
Astura Medical appears in FDA device records in Irving, TX. FDA records list 29 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 29 510(k) clearances for Astura Medical between 2016 and 2026. The busiest year on record is 2018, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 5 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 5 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | PML | Substantially Equivalent | |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | NKB | Substantially Equivalent | |
| K243259 | MASADA Modular Spinal Fixation System | NKB | Substantially Equivalent | |
| K240160 | EGPS Navigated Instruments | OLO | Substantially Equivalent | |
| K233359 | DOMINION Expandable Corpectomy System | MQP | Substantially Equivalent | |
| K231694 | MASADA Modular Spinal Fixation System | NKB | Substantially Equivalent | |
| K232211 | REUNION Sacroiliac Joint Fusion System | OUR | Substantially Equivalent | |
| K223335 | SIRION Lateral Lumbar Interbody System | MAX | Substantially Equivalent | |
| K222097 | OLYMPIC Deformity Band System | OWI | Substantially Equivalent | |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | OVD | Substantially Equivalent | |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System | OVD | Substantially Equivalent | |
| K202495 | SIRION Lateral Lumbar Interbody Fusion | MAX | Substantially Equivalent | |
| K202065 | DOLOMITE Anterior Cervical Stabilization System | OVE | Substantially Equivalent | |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | OVD | Substantially Equivalent | |
| K192006 | SIRION Lateral Lumbar Interbody System | MAX | Substantially Equivalent | |
| K190426 | ALTA Anterior Cervical Corpectomy System | PLR | Substantially Equivalent | |
| K182877 | HALF DOME Posterior Lumbar Interbody System | MAX | Substantially Equivalent | |
| K182982 | BridalVeil Navigated Instruments | OLO | Substantially Equivalent | |
| K182239 | OLYMPIC Posterior Spinal Fixation System | NKB | Substantially Equivalent | |
| K181139 | OLYMPIC Posterior Spinal Fixation System | NKB | Substantially Equivalent | |
| K172166 | OLYMPIC Navigated Instruments | OLO | Substantially Equivalent | |
| K172947 | HALF DOME Posterior Lumbar Interbody System | MAX | Substantially Equivalent | |
| K173324 | ALTA Anterior Cervical Interbody Spacer | ODP | Substantially Equivalent | |
| K171250 | BRIDALVEIL Occipital Cervical Thoracic System | NKG | Substantially Equivalent | |
| K163481 | HALF DOME Posterior Lumbar Interbody System | MAX | Substantially Equivalent | |
| K160702 | ZION Anterior Cervical Fixation System | KWQ | Substantially Equivalent | |
| K160154 | ALTA Anterior Cervical Interbody Spacer | ODP | Substantially Equivalent | |
| K153446 | OLYMPIC Posterior Spinal Fixation System | OSH | Substantially Equivalent | |
| K152512 | Half Dome Posterior Lumbar Interbody System | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015941638 | 3011764740 | Astura Medical | 4949 W Royal Ln, Irving, TX 75063 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- PMLBone Cement, Posterior Screw Augmentation
- OWIBone Fixation Cerclage, Sublaminar
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- NKGPosterior Cervical Screw System
- GADRetractor
- OURSacroiliac Joint Fixation
- MQPSpinal Vertebral Body Replacement Device
- PLRSpinal Vertebral Body Replacement Device - Cervical
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain