Medical Device Manufacturer · US , Englewood , CO

Aegis Spine, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2021
5
Total
5
Cleared
0
Denied

Aegis Spine, Inc. has 5 FDA 510(k) cleared medical devices. Based in Englewood, US.

Last cleared in 2023. Active since 2021. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Aegis Spine, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Empirical Testing Corp as regulatory consultant.

FDA 510(k) Regulatory Record - Aegis Spine, Inc.
5 devices
1-5 of 5
Cleared Jan 20, 2023
ZESPIN SI Joint Fusion System
K223521 · OUR
Orthopedic · 58d
Cleared Jan 11, 2023
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
K223719 · KWQ
Orthopedic · 30d
Cleared Nov 03, 2022
ABTross ALIF Expandable Cage System
K221719 · MAX
Orthopedic · 143d
Cleared Jun 30, 2022
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System,...
K221050 · OUR
Orthopedic · 80d
Cleared Jan 29, 2021
XYPAN Expandable Lumbar Cage System
K203531 · MAX
Orthopedic · 58d
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