Atlas Spine, Inc.
FDA Regulatory Profile
Atlas Spine, Inc. appears in FDA public data with 2 recalls, 19 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1616-2016, Class II) was initiated on July 26, 2013. Its most recent 510(k) clearance was granted on July 15, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 19
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1616-2016 | Class II | Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into | July 26, 2013 |
| Z-2274-2012 | Class II | Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas | June 4, 2009 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant | July 15, 2026 |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy System | November 10, 2025 |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | August 15, 2025 |
| K243191 | Atlas Spine Lateral Expandable Interbody System | November 26, 2024 |
| K202302 | Atlas Spine Rebar (Ti) Spacer System | October 30, 2020 |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | February 28, 2020 |
| K182418 | V3 Segmental Plating System | November 29, 2018 |
| K180675 | Atlas Spine Expandable Cervical Interbody System | June 13, 2018 |
| K172334 | Ortus Expandable Lumbar Interbody Fusion System | October 25, 2017 |
| K162918 | Atlas Spine Expandable Interbody System | February 9, 2017 |
| K112759 | APCLO PEDICLE SCREW SYSTEMS | October 18, 2011 |
| K110842 | ATLAS SPINE PEDICLE SCREW SYSTEM | July 13, 2011 |
| K100743 | ATLAS SPINE PIVOTING SYSTEM | August 10, 2010 |
| K091406 | ATLAS SPINE SPACER | September 4, 2009 |
| K081880 | ATLAS SPINE SPACER | October 2, 2008 |
| K072426 | ATLAS SPINE PEDICLE SCREW SYSTEM | October 19, 2007 |
| K071497 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | June 29, 2007 |
| K063464 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | March 9, 2007 |
| K063205 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | February 26, 2007 |