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Data / Medical devices / United States / Astura Medical

Astura Medical: FDA-registered device maker in Irving, TX, United States, 29 510(k) clearances

Astura Medical is registered with the FDA (registration 3015941638) in Irving, TX, United States. It lists 19 device types. The FDA files 29 510(k) clearances under its listings, the newest dated January 22, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Astura Medical
FDA registration number
3015941638
FEI number
3011764740
Address
4949 W Royal Ln, Irving, TX, United States, 75063
Owner or operator
Astura Medical (10051052)
Roles
Complaint file establishment, Repackager or relabeler, Specification developer
First device listed
January 28, 2016
Registered through
2026
Brand names listed
ALTA Cervical Interbody Spacer, BRIDALVEIL Occipital Cervical Thoracic System, HALF DOME PLIS, OLYMPIC Deformity Band System, ZION Anterior Cervical Fixation System

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Specification developeraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Complaint file establishment, Specification developeraccessdata.fda.gov
Bone Fixation Cerclage, SublaminarOWI2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Specification developeraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Complaint file establishment, Specification developeraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Complaint file establishment, Specification developeraccessdata.fda.gov
RetractorGAD1Complaint file establishment, Specification developeraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Complaint file establishment, Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Complaint file establishment, Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Complaint file establishment, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 22, 2026K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemPMLSubstantially EquivalentAstura Medicalaccessdata.fda.gov
October 21, 2025K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemNKBSubstantially EquivalentAstura Medicalaccessdata.fda.gov
January 7, 2025K243259MASADA Modular Spinal Fixation SystemNKBSubstantially EquivalentAstura Medicalaccessdata.fda.gov
October 17, 2024K240160EGPS Navigated InstrumentsOLOSubstantially EquivalentAstura Medicalaccessdata.fda.gov
March 8, 2024K233359DOMINION Expandable Corpectomy SystemMQPSubstantially EquivalentAstura Medicalaccessdata.fda.gov
November 16, 2023K231694MASADA Modular Spinal Fixation SystemNKBSubstantially EquivalentAstura Medicalaccessdata.fda.gov
October 24, 2023K232211REUNION Sacroiliac Joint Fusion SystemOURSubstantially EquivalentAstura Medicalaccessdata.fda.gov
May 9, 2023K223335SIRION Lateral Lumbar Interbody SystemMAXSubstantially EquivalentAstura Medicalaccessdata.fda.gov
May 4, 2023K222097OLYMPIC Deformity Band SystemOWISubstantially EquivalentAstura Medicalaccessdata.fda.gov
January 19, 2023K222554EL CAPITAN Anterior Lumbar Interbody FusionOVDSubstantially EquivalentAstura Medicalaccessdata.fda.gov
March 30, 2022K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemOVDSubstantially EquivalentAstura Medicalaccessdata.fda.gov
January 6, 2021K202495SIRION Lateral Lumbar Interbody FusionMAXSubstantially EquivalentAstura Medical, LLCaccessdata.fda.gov
October 26, 2020K202065DOLOMITE Anterior Cervical Stabilization SystemOVESubstantially EquivalentAstura Medical, LLCaccessdata.fda.gov
April 21, 2020K192492EL CAPITAN Anterior Lumber Interbody SystemOVDSubstantially EquivalentAstura Medical, LLCaccessdata.fda.gov
April 2, 2020K192006SIRION Lateral Lumbar Interbody SystemMAXSubstantially EquivalentAstura Medical, LLCaccessdata.fda.gov
October 24, 2019K190426ALTA Anterior Cervical Corpectomy SystemPLRSubstantially EquivalentAstura Medical, LLCaccessdata.fda.gov
May 3, 2019K182877HALF DOME Posterior Lumbar Interbody SystemMAXSubstantially EquivalentAstura Medical, LLCaccessdata.fda.gov
January 4, 2019K182982BridalVeil Navigated InstrumentsOLOSubstantially EquivalentAstura Medicalaccessdata.fda.gov
October 18, 2018K182239OLYMPIC Posterior Spinal Fixation SystemNKBSubstantially EquivalentAstura Medical, LLCaccessdata.fda.gov
July 6, 2018K181139OLYMPIC Posterior Spinal Fixation SystemNKBSubstantially EquivalentAstura Medical, LLCaccessdata.fda.gov
April 27, 2018K172166OLYMPIC Navigated InstrumentsOLOSubstantially EquivalentAstura Medicalaccessdata.fda.gov
April 18, 2018K172947HALF DOME Posterior Lumbar Interbody SystemMAXSubstantially EquivalentAstura Medicalaccessdata.fda.gov
February 27, 2018K173324ALTA Anterior Cervical Interbody SpacerODPSubstantially EquivalentAstura Medicalaccessdata.fda.gov
October 2, 2017K171250BRIDALVEIL Occipital Cervical Thoracic SystemNKGSubstantially EquivalentAstura Medicalaccessdata.fda.gov
May 3, 2017K163481HALF DOME Posterior Lumbar Interbody SystemMAXSubstantially EquivalentAstura Medicalaccessdata.fda.gov
August 23, 2016K160702ZION Anterior Cervical Fixation SystemKWQSubstantially EquivalentAstura Medicalaccessdata.fda.gov
May 13, 2016K160154ALTA Anterior Cervical Interbody SpacerODPSubstantially EquivalentAstura Medicalaccessdata.fda.gov
April 8, 2016K153446OLYMPIC Posterior Spinal Fixation SystemOSHSubstantially EquivalentAstura Medicalaccessdata.fda.gov
January 28, 2016K152512Half Dome Posterior Lumbar Interbody SystemMAXSubstantially EquivalentAstura Medicalaccessdata.fda.gov

Compare with other makers

Updated January 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.