PLR — Spinal Vertebral Body Replacement Device - Cervical Class II
FDA product code PLR covers "Spinal Vertebral Body Replacement Device - Cervical", a Class II medical device regulated under 21 CFR 888.3060. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 19 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252822 | atlas spine | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant | July 15, 2026 |
| 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 |