510(k) K252560
K252560 is an FDA 510(k) premarket notification submitted by Atlas Spine, Inc. for the device "Atlas Spine HiRISE Expandable Cervical Corpectomy System". The FDA issued a decision of Substantially Equivalent on November 10, 2025. The device falls under product code PLR (Spinal Vertebral Body Replacement Device - Cervical), a Class II device regulated under 21 CFR 888.3060. Atlas Spine, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2025
- Date Received
- August 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Vertebral Body Replacement Device - Cervical
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
Vertebral body replacement in the cervical spine.