Aegis Spine, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Aegis Spine, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ZESPIN SI Joint Fusion System, Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System, ABTross ALIF Expandable Cage System
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
Cleared
Jan 20, 2023
ZESPIN SI Joint Fusion System
Orthopedic
58d
Cleared
Jan 11, 2023
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
Orthopedic
30d
Cleared
Nov 03, 2022
ABTross ALIF Expandable Cage System
Orthopedic
143d
Cleared
Jun 30, 2022
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System,...
Orthopedic
80d
Cleared
Jan 29, 2021
XYPAN Expandable Lumbar Cage System
Orthopedic
58d