PLR
- Product code
- PLR
- Device name
- Spinal Vertebral Body Replacement Device - Cervical
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3060
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 19 (all years; only the last 3 years are listed here)
FDA classification definition
Vertebral body replacement in the cervical spine.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252822 | 2026-07-15 | Atlas Spine, Inc. | Atlas Spine HiRISE Expandable Cervical-p Corpectomy | |
| K252560 | 2025-11-10 | Atlas Spine, Inc. | Atlas Spine HiRISE Expandable Cervical Corpectomy S | — |
| K232481 | 2023-10-13 | MiRus, LLC | RIGEL 3DR Anterior Cervical Corpectomy System | FDA |
Official FDA classification page: PLR
Classification and pathway per current FDA publications. Data from openFDA (CC0).