Company · US
Atlas Spine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2026 | K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant Atlas Spine, Inc. | PLR |
| Nov 10, 2025 | K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy System Atlas Spine, Inc. | PLR |
| Aug 15, 2025 | K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System Atlas Spine, Inc. | MAX |
| Nov 26, 2024 | K243191 | Atlas Spine Lateral Expandable Interbody System Atlas Spine, Inc. | OVD |
| Oct 30, 2020 | K202302 | Atlas Spine Rebar (Ti) Spacer System Atlas Spine, Inc. | ODP |
| Feb 28, 2020 | K192570 | Atlas Spine Expandable Cervical Standalone Interbody System Atlas Spine, Inc. | OVE |
| Nov 29, 2018 | K182418 | V3 Segmental Plating System Atlas Spine, Inc. | KWQ |
| Jun 13, 2018 | K180675 | Atlas Spine Expandable Cervical Interbody System Atlas Spine, Inc. | ODP |
| Oct 25, 2017 | K172334 | Ortus Expandable Lumbar Interbody Fusion System Atlas Spine, Inc. | MAX |
| Feb 9, 2017 | K162918 | Atlas Spine Expandable Interbody System Atlas Spine, Inc. | MAX |
| Oct 18, 2011 | K112759 | APCLO PEDICLE SCREW SYSTEMS Atlas Spine, Inc. | NKB |
| Jul 13, 2011 | K110842 | ATLAS SPINE PEDICLE SCREW SYSTEM Atlas Spine, Inc. | NKB |
| Aug 10, 2010 | K100743 | ATLAS SPINE PIVOTING SYSTEM Atlas Spine, Inc. | MAX |
| Sep 4, 2009 | K091406 | ATLAS SPINE SPACER Atlas Spine, LLC | MQP |
| Oct 2, 2008 | K081880 | ATLAS SPINE SPACER Atlas Spine, Inc. | ODP |
| Oct 19, 2007 | K072426 | ATLAS SPINE PEDICLE SCREW SYSTEM Atlas Spine, LLC | NKB |
| Jun 29, 2007 | K071497 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT Atlas Spine, Inc. | MQP |
| Mar 9, 2007 | K063464 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT Atlas Spine, Inc. | MQP |
| Feb 26, 2007 | K063205 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT Atlas Spine, LLC | MQP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2013 | Atlas Spine, Inc. Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000
Used to rotate implant into position Terminated |
MQP | K063205 K091406 |
| Aug 27, 2012 | Atlas Spine, Inc. Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1 Terminated |
NKB | K072426 |