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

FDA 510(k) cleared devices by Astura Medical Orthopedic

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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