Medical Device Manufacturer · US , Jupiter , FL

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

16 submissions · 16 cleared · Since 2007

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
1-16 of 16
Cleared Jul 15, 2026
Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
K252822 · PLR
Orthopedic · 314d
Cleared Nov 10, 2025
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
K252560 · PLR
Orthopedic · 89d
Cleared Aug 15, 2025
Atlas Spine Project X Expandable Posterior Lumbar Interbody System
K251969 · MAX
Orthopedic · 50d
Cleared Nov 26, 2024
Atlas Spine Lateral Expandable Interbody System
K243191 · OVD
Orthopedic · 57d
Cleared Oct 30, 2020
Atlas Spine Rebar (Ti) Spacer System
K202302 · ODP
Orthopedic · 77d
Cleared Feb 28, 2020
Atlas Spine Expandable Cervical Standalone Interbody System
K192570 · OVE
Orthopedic · 163d
Cleared Nov 29, 2018
V3 Segmental Plating System
K182418 · KWQ
Orthopedic · 85d
Cleared Jun 13, 2018
Atlas Spine Expandable Cervical Interbody System
K180675 · ODP
Orthopedic · 90d
Cleared Oct 25, 2017
Ortus™ Expandable Lumbar Interbody Fusion System
K172334 · MAX
Orthopedic · 84d
Cleared Feb 09, 2017
Atlas Spine Expandable Interbody System
K162918 · MAX
Orthopedic · 114d
Cleared Oct 18, 2011
APCLO PEDICLE SCREW SYSTEMS
K112759 · NKB
Orthopedic · 26d
Cleared Jul 13, 2011
ATLAS SPINE PEDICLE SCREW SYSTEM
K110842 · NKB
Orthopedic · 110d
Cleared Aug 10, 2010
ATLAS SPINE PIVOTING SYSTEM
K100743 · MAX
Orthopedic · 147d
Cleared Oct 02, 2008
ATLAS SPINE SPACER
K081880 · ODP
Orthopedic · 92d
Cleared Jun 29, 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K071497 · MQP
Orthopedic · 29d
Cleared Mar 09, 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K063464 · MQP
Orthopedic · 113d
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