Product code PLR
- Device name
- Spinal Vertebral Body Replacement Device - Cervical
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3060
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Vertebral body replacement in the cervical spine.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252822 | Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. | 2026-07-15 |
| K252560 | Atlas Spine HiRISE™ Expandable Cervical Corpectomy System | Atlas Spine, Inc. | 2025-11-10 |
| K232481 | RIGEL™ 3DR Anterior Cervical Corpectomy System | MiRus, LLC | 2023-10-13 |
| K221542 | Galileo Vertebral Body Replacement Device | Bright Spine | 2023-01-13 |
| K212126 | MediExpand Cervical Expandable VBR System | Cmf Medicon Surgical, Inc. | 2022-04-04 |
| K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022-02-24 |
| K192145 | Galileo Vertebral Body Replacement Device | Bright Spine | 2020-04-21 |
| K193412 | NEXXT MATRIXX System | Nexxt Spine, LLC | 2020-02-24 |
| K190284 | Bengal Stackable Cage System | Medos International SARL | 2019-12-20 |
| K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | 2019-10-24 |
| K191778 | Omnia Medical VBR | Omnia Medical, LLC | 2019-08-28 |
| K191423 | Normandy VBR System | Zavation Medical Products, LLC | 2019-08-06 |
| K183071 | VLIFT-s Vertebral Body Replacement System | Stryker Spine | 2019-01-10 |
| K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | 2018-11-20 |
| K173893 | Trabis | Coligne AG | 2018-09-06 |
| K180673 | Normandy VBR System | Zavation Medical Products, LLC | 2018-07-13 |
| K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017-11-20 |
| K152568 | C-VBR | Cardinal Spine, LLC | 2016-02-11 |
| K151651 | NuVasive X-CORE Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | 2015-09-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10888857461819 | CASCADIA™ Interbody System | VB Spine LLC | 2019-10-31 |
| 10888857461888 | CASCADIA™ Interbody System | VB Spine LLC | 2019-10-31 |
| 10888857218963 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 10888857219076 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 10888857219489 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 10888857219595 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 10888857218772 | CASCADIA™ Interbody System | VB Spine LLC | 2015-12-16 |
| 10888857021570 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857022416 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021662 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021747 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021822 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021907 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021983 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857022065 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857022225 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857022324 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857022379 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021495 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021419 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021334 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021259 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021174 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021082 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857021006 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857020924 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857020900 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857020870 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857020856 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |
| 10888857020825 | SANTORINI™ Corpectomy Cage System | VB Spine LLC | 2015-09-24 |