K252822
- 510(k) number
- K252822
- Device name
- Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
- Applicant
- Atlas Spine, Inc. FL · US
- Product code
- PLR — Spinal Vertebral Body Replacement Device - Cervical
- Decision date
- 2026-07-15
- Date received
- 2025-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252822.pdf
Official FDA record: K252822
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.