PLR — Spinal Vertebral Body Replacement Device - Cervical Class II
Classification Details
- Product Code
- PLR
- Device Class
- Class II
- Regulation Number
- 888.3060
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Vertebral body replacement in the cervical spine.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252560 | atlas spine | Atlas Spine HiRISE Expandable Cervical Corpectomy System | November 10, 2025 |
| K232481 | mirus | RIGEL 3DR Anterior Cervical Corpectomy System | October 13, 2023 |
| K221542 | bright spine | Galileo Vertebral Body Replacement Device | January 13, 2023 |
| K212126 | cmf medicon surgical | MediExpand Cervical Expandable VBR System | April 4, 2022 |
| K211320 | k2m | CAPRI Corpectomy Cage System | February 24, 2022 |
| K192145 | bright spine | Galileo Vertebral Body Replacement Device | April 21, 2020 |
| K193412 | nexxt spine | NEXXT MATRIXX System | February 24, 2020 |
| K190284 | medos international sarl | Bengal Stackable Cage System | December 20, 2019 |
| K190426 | astura medical | ALTA Anterior Cervical Corpectomy System | October 24, 2019 |
| K191778 | omnia medical | Omnia Medical VBR | August 28, 2019 |
| K191423 | zavation medical products | Normandy VBR System | August 6, 2019 |
| K183071 | stryker spine | VLIFT-s Vertebral Body Replacement System | January 10, 2019 |
| K180550 | nu vasive, incorporated | NuVasive Monolith Cervical Corpectomy System | November 20, 2018 |
| K173893 | coligne | Trabis | September 6, 2018 |
| K180673 | zavation medical products | Normandy VBR System | July 13, 2018 |
| K172032 | aesculap implants systems | Modulift Vertebral Body Replacement (VBR) System | November 20, 2017 |
| K152568 | cardinal spine | C-VBR | February 11, 2016 |
| K151651 | nu vasive, incorporated | NuVasive X-CORE Mini Cervical Expandable VBR System | September 25, 2015 |