Medical Device Manufacturer · US , Carlsbad , CA

Astura Medical - FDA 510(k) Cleared Devices

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

Astura Medical has 21 FDA 510(k) cleared orthopedic devices. Based in Carlsbad, US.

Latest FDA clearance: Jan 2026. Active since 2016.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Astura Medical
21 devices
1-21 of 21
Cleared Jan 22, 2026
OLYMPIC Posterior Spinal Fixation System
K252885 · PML
Orthopedic · 134d
Cleared Oct 21, 2025
OLYMPIC Posterior Spinal Fixation System
K252346 · NKB
Orthopedic · 85d
Cleared Jan 07, 2025
MASADA Modular Spinal Fixation System
K243259 · NKB
Orthopedic · 84d
Cleared Oct 17, 2024
EGPS Navigated Instruments
K240160 · OLO
Orthopedic · 272d
Cleared Mar 08, 2024
DOMINION Expandable Corpectomy System
K233359 · MQP
Orthopedic · 161d
Cleared Nov 16, 2023
MASADA Modular Spinal Fixation System
K231694 · NKB
Orthopedic · 160d
Cleared Oct 24, 2023
REUNION Sacroiliac Joint Fusion System
K232211 · OUR
Orthopedic · 90d
Cleared May 09, 2023
SIRION Lateral Lumbar Interbody System
K223335 · MAX
Orthopedic · 189d
Cleared May 04, 2023
OLYMPIC Deformity Band System
K222097 · OWI
Orthopedic · 290d
Cleared Jan 19, 2023
EL CAPITAN Anterior Lumbar Interbody Fusion
K222554 · OVD
Orthopedic · 149d
Cleared Mar 30, 2022
EL CAPITAN Anterior Lumbar Interbody Fusion System
K214047 · OVD
Orthopedic · 93d
Cleared Jan 04, 2019
BridalVeil Navigated Instruments
K182982 · OLO
Orthopedic · 67d
Cleared Apr 27, 2018
OLYMPIC Navigated Instruments
K172166 · OLO
Orthopedic · 283d
Cleared Apr 18, 2018
HALF DOME Posterior Lumbar Interbody System
K172947 · MAX
Orthopedic · 204d
Cleared Feb 27, 2018
ALTA Anterior Cervical Interbody Spacer
K173324 · ODP
Orthopedic · 130d
Cleared Oct 02, 2017
BRIDALVEIL Occipital Cervical Thoracic System
K171250 · NKG
Orthopedic · 157d
Cleared May 03, 2017
HALF DOME Posterior Lumbar Interbody System
K163481 · MAX
Orthopedic · 142d
Cleared Aug 23, 2016
ZION Anterior Cervical Fixation System
K160702 · KWQ
Orthopedic · 162d
Cleared May 13, 2016
ALTA Anterior Cervical Interbody Spacer
K160154 · ODP
Orthopedic · 114d
Cleared Apr 08, 2016
OLYMPIC Posterior Spinal Fixation System
K153446 · OSH
Orthopedic · 133d
Cleared Jan 28, 2016
Half Dome Posterior Lumbar Interbody System
K152512 · MAX
Orthopedic · 148d
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