Medical Device Manufacturer · US , Jupiter , FL

Atlas Spine, Inc.

15 submissions · 15 cleared · Since 2007
15
Total
15
Cleared
0
Denied

Atlas Spine, Inc. — FDA 510(k) Submissions

Atlas Spine, Inc. has submitted 15 FDA 510(k) premarket notifications since 2007, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Intervertebral Fusion Device With Bone Graft, Cervical, Spinal Vertebral Body Replacement Device, Thoracolumbosacral Pedicle Screw System, Spinal Vertebral Body Replacement Device - Cervical . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
Atlas Spine HiRISE? Expandable Cervical Corpectomy System
K252560 · PLR Spinal Vertebral Body... · Orthopedic
Nov 2025 89d
Atlas Spine Project X Expandable Posterior Lumbar Interbody System
K251969 · MAX Intervertebral Fusion... · Orthopedic
Aug 2025 50d
Atlas Spine Lateral Expandable Interbody System
K243191 · OVD Intervertebral Fusion... · Orthopedic
Nov 2024 57d
Atlas Spine Rebar (Ti) Spacer System
K202302 · ODP Intervertebral Fusion... · Orthopedic
Oct 2020 77d
Atlas Spine Expandable Cervical Standalone Interbody System
K192570 · OVE Intervertebral Fusion... · Orthopedic
Feb 2020 163d
V3 Segmental Plating System
K182418 · KWQ Appliance, Fixation,... · Orthopedic
Nov 2018 85d
Atlas Spine Expandable Cervical Interbody System
K180675 · ODP Intervertebral Fusion... · Orthopedic
Jun 2018 90d
Ortus? Expandable Lumbar Interbody Fusion System
K172334 · MAX Intervertebral Fusion... · Orthopedic
Oct 2017 84d
Atlas Spine Expandable Interbody System
K162918 · MAX Intervertebral Fusion... · Orthopedic
Feb 2017 114d
APCLO PEDICLE SCREW SYSTEMS
K112759 · NKB Thoracolumbosacral... · Orthopedic
Oct 2011 26d
ATLAS SPINE PEDICLE SCREW SYSTEM
K110842 · NKB Thoracolumbosacral... · Orthopedic
Jul 2011 110d
ATLAS SPINE PIVOTING SYSTEM
K100743 · MAX Intervertebral Fusion... · Orthopedic
Aug 2010 147d
ATLAS SPINE SPACER
K081880 · ODP Intervertebral Fusion... · Orthopedic
Oct 2008 92d
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K071497 · MQP Spinal Vertebral Body... · Orthopedic
Jun 2007 29d
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K063464 · MQP Spinal Vertebral Body... · Orthopedic
Mar 2007 113d
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