Spinal Vertebral Body Replacement Device - Cervical
FDA product code PLR · Class II (moderate risk) · 21 CFR 888.3060 · Orthopedic
Vertebral body replacement in the cervical spine.
19510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
- Nu Vasive, Incorporated 2
- Zavation Medical Products, LLC 2
- Bright Spine 2
- Atlas Spine, Inc. 2
- Cardinal Spine, LLC 1
- Aesculap Implants Systems, LLC 1
- Coligne AG 1
- Stryker Spine 1
- Omnia Medical, LLC 1
- Astura Medical 1
- Medos International SARL 1
- Nexxt Spine, LLC 1
- K2m, Inc. 1
- Cmf Medicon Surgical, Inc. 1
- MiRus, LLC 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | Atlas Spine, Inc. | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | Atlas Spine, Inc. | 11/10/2025SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | MiRus, LLC | 10/13/2023SE |
| K221542 | Galileo Vertebral Body Replacement DevicePLR · Special | Bright Spine | 01/13/2023SE |
| K212126 | MediExpand Cervical Expandable VBR SystemPLR · Traditional | Cmf Medicon Surgical, Inc. | 04/04/2022SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | K2m, Inc. | 02/24/2022SE |
| K192145 | Galileo Vertebral Body Replacement DevicePLR · Traditional | Bright Spine | 04/21/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | Nexxt Spine, LLC | 02/24/2020SE |
| K190284 | Bengal Stackable Cage SystemPLR · Traditional | Medos International SARL | 12/20/2019SE |
| K190426 | ALTA Anterior Cervical Corpectomy SystemPLR · Traditional | Astura Medical, LLC | 10/24/2019SE |
| K191778 | Omnia Medical VBRPLR · Special | Omnia Medical, LLC | 08/28/2019SE |
| K191423 | Normandy VBR SystemPLR · Traditional | Zavation Medical Products, LLC | 08/06/2019SE |
| K183071 | VLIFT-s Vertebral Body Replacement SystemPLR · Special | Stryker Spine | 01/10/2019SE |
| K180550 | NuVasive Monolith Cervical Corpectomy SystemPLR · Traditional | Nu Vasive, Incorporated | 11/20/2018SE |
| K173893 | TrabisPLR · Traditional | Coligne AG | 09/06/2018SE |
| K180673 | Normandy VBR SystemPLR · Traditional | Zavation Medical Products, LLC | 07/13/2018SE |
| K172032 | Modulift Vertebral Body Replacement (VBR) SystemPLR · Traditional | Aesculap Implants Systems, Inc. | 11/20/2017SE |
| K152568 | C-VbrPLR · Traditional | Cardinal Spine, LLC | 02/11/2016SE |
| K151651 | NuVasive X-CORE Mini Cervical Expandable VBR SystemPLR · Traditional | Nu Vasive, Incorporated | 09/25/2015SE |