Medical Device Manufacturer · US , Jupiter , FL

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

15 submissions · 15 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

15
Total
15
Cleared
0
Denied

FDA 510(k) Regulatory Record - Atlas Spine, Inc. Orthopedic ✕

15 devices
1-12 of 15
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
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