FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Atlas Spine HiRISE Expandable Cervical Corpectomy System
K Number: K252560
·
Decision Nov 10, 2025
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
17
Applicant Total
15
Review Days
89
Basic Information
- Device Name
- Atlas Spine HiRISE Expandable Cervical Corpectomy System
- K Number
- K252560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Atlas Spine, Inc.
- Date Received
- August 13, 2025
- Decision Date
- November 10, 2025
- Product Code
- PLR
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLR | Spinal Vertebral Body Replacement Device - Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PLR), ordered by most recent decision date.
RIGEL 3DR Anterior Cervical Corpectomy System
FDA 510(k)
FDA Class 2
·Orthopedic
Galileo Vertebral Body Replacement Device
FDA 510(k)
FDA Class 2
·Orthopedic
MediExpand Cervical Expandable VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
CAPRI Corpectomy Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Galileo Vertebral Body Replacement Device
FDA 510(k)
FDA Class 2
·Orthopedic
NEXXT MATRIXX System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Atlas Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | Aug 15, 2025 | Substantially Equivalent |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Nov 26, 2024 | Substantially Equivalent |
| K202302 | Atlas Spine Rebar (Ti) Spacer System | Oct 30, 2020 | Substantially Equivalent |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | Feb 28, 2020 | Substantially Equivalent |
| K182418 | V3 Segmental Plating System | Nov 29, 2018 | Substantially Equivalent |
| K180675 | Atlas Spine Expandable Cervical Interbody System | Jun 13, 2018 | Substantially Equivalent |
| K172334 | Ortus Expandable Lumbar Interbody Fusion System | Oct 25, 2017 | Substantially Equivalent |
| K162918 | Atlas Spine Expandable Interbody System | Feb 9, 2017 | Substantially Equivalent |
| K112759 | APCLO PEDICLE SCREW SYSTEMS | Oct 18, 2011 | Substantially Equivalent |
| K110842 | ATLAS SPINE PEDICLE SCREW SYSTEM | Jul 13, 2011 | Substantially Equivalent |