Medical Device Manufacturer · US , Carlsbad , CA

Astura Medical

21 submissions · 21 cleared · Since 2016
21
Total
21
Cleared
0
Denied

Astura Medical — FDA 510(k) Submissions

Astura Medical has submitted 21 FDA 510(k) premarket notifications since 2016, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Orthopedic Stereotaxic Instrument, Thoracolumbosacral Pedicle Screw System, Intervertebral Fusion Device With Bone Graft, Cervical, Intervertebral Fusion Device With Integrated Fixation, Lumbar . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
K252885 · PML Bone Cement, Posterior... · Orthopedic
Jan 2026 134d
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
K252346 · NKB Thoracolumbosacral... · Orthopedic
Oct 2025 85d
MASADA Modular Spinal Fixation System
K243259 · NKB Thoracolumbosacral... · Orthopedic
Jan 2025 84d
EGPS Navigated Instruments
K240160 · OLO Orthopedic Stereotaxic... · Orthopedic
Oct 2024 272d
DOMINION Expandable Corpectomy System
K233359 · MQP Spinal Vertebral Body... · Orthopedic
Mar 2024 161d
MASADA Modular Spinal Fixation System
K231694 · NKB Thoracolumbosacral... · Orthopedic
Nov 2023 160d
REUNION Sacroiliac Joint Fusion System
K232211 · OUR Sacroiliac Joint Fixation · Orthopedic
Oct 2023 90d
SIRION Lateral Lumbar Interbody System
K223335 · MAX Intervertebral Fusion... · Orthopedic
May 2023 189d
OLYMPIC Deformity Band System
K222097 · OWI Bone Fixation Cerclage,... · Orthopedic
May 2023 290d
EL CAPITAN Anterior Lumbar Interbody Fusion
K222554 · OVD Intervertebral Fusion... · Orthopedic
Jan 2023 149d
EL CAPITAN Anterior Lumbar Interbody Fusion System
K214047 · OVD Intervertebral Fusion... · Orthopedic
Mar 2022 93d
BridalVeil Navigated Instruments
K182982 · OLO Orthopedic Stereotaxic... · Orthopedic
Jan 2019 67d
OLYMPIC Navigated Instruments
K172166 · OLO Orthopedic Stereotaxic... · Orthopedic
Apr 2018 283d
HALF DOME Posterior Lumbar Interbody System
K172947 · MAX Intervertebral Fusion... · Orthopedic
Apr 2018 204d
ALTA Anterior Cervical Interbody Spacer
K173324 · ODP Intervertebral Fusion... · Orthopedic
Feb 2018 130d
BRIDALVEIL Occipital Cervical Thoracic System
K171250 · NKG Posterior Cervical Screw... · Orthopedic
Oct 2017 157d
HALF DOME Posterior Lumbar Interbody System
K163481 · MAX Intervertebral Fusion... · Orthopedic
May 2017 142d
ZION Anterior Cervical Fixation System
K160702 · KWQ Appliance, Fixation,... · Orthopedic
Aug 2016 162d
ALTA Anterior Cervical Interbody Spacer
K160154 · ODP Intervertebral Fusion... · Orthopedic
May 2016 114d
OLYMPIC Posterior Spinal Fixation System
K153446 · OSH Pedicle Screw Spinal... · Orthopedic
Apr 2016 133d
Half Dome Posterior Lumbar Interbody System
K152512 · MAX Intervertebral Fusion... · Orthopedic
Jan 2016 148d
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