Atlas Spine, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Atlas Spine, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Atlas Spine HiRISE™ Expandable Cervical Corpectomy System, Atlas Spine Project X Expandable Posterior Lumbar Interbody System, Atlas Spine Lateral Expandable Interbody System
16
Total
16
Cleared
0
Denied
Atlas Spine, Inc. has 16 FDA 510(k) cleared orthopedic devices. Based in Jupiter, US.
Latest FDA clearance: Jul 2026. Active since 2007.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Empirical Consulting, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Atlas Spine, Inc.
16 devices
Cleared
Jul 15, 2026
Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
Orthopedic
314d
Cleared
Nov 10, 2025
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
Orthopedic
89d
Cleared
Aug 15, 2025
Atlas Spine Project X Expandable Posterior Lumbar Interbody System
Orthopedic
50d
Cleared
Nov 26, 2024
Atlas Spine Lateral Expandable Interbody System
Orthopedic
57d
Cleared
Oct 30, 2020
Atlas Spine Rebar (Ti) Spacer System
Orthopedic
77d
Cleared
Feb 28, 2020
Atlas Spine Expandable Cervical Standalone Interbody System
Orthopedic
163d
Cleared
Nov 29, 2018
V3 Segmental Plating System
Orthopedic
85d
Cleared
Jun 13, 2018
Atlas Spine Expandable Cervical Interbody System
Orthopedic
90d
Cleared
Oct 25, 2017
Ortus™ Expandable Lumbar Interbody Fusion System
Orthopedic
84d
Cleared
Feb 09, 2017
Atlas Spine Expandable Interbody System
Orthopedic
114d
Cleared
Oct 18, 2011
APCLO PEDICLE SCREW SYSTEMS
Orthopedic
26d
Cleared
Jul 13, 2011
ATLAS SPINE PEDICLE SCREW SYSTEM
Orthopedic
110d