PLR · Spinal Vertebral Body Replacement Device - Cervical
Orthopedic · 21 CFR 888.3060 · Class 2
Overview
| Product Code | PLR |
|---|---|
| Device Name | Spinal Vertebral Body Replacement Device - Cervical |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
Classification Rationale
Class II.
Cleared Devices (18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy System | Atlas Spine, Inc. | Nov 10, 2025 | SESE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy System | MiRus, LLC | Oct 13, 2023 | SESE |
| K221542 | Galileo Vertebral Body Replacement Device | Bright Spine | Jan 13, 2023 | SESE |
| K212126 | MediExpand Cervical Expandable VBR System | Cmf Medicon Surgical, Inc. | Apr 4, 2022 | SESE |
| K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | Feb 24, 2022 | SESE |
| K192145 | Galileo Vertebral Body Replacement Device | Bright Spine | Apr 21, 2020 | SESE |
| K193412 | NEXXT MATRIXX System | Nexxt Spine, LLC | Feb 24, 2020 | SESE |
| K190284 | Bengal Stackable Cage System | Medos International SARL | Dec 20, 2019 | SESE |
| K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | Oct 24, 2019 | SESE |
| K191778 | Omnia Medical VBR | Omnia Medical, LLC | Aug 28, 2019 | SESE |
| K191423 | Normandy VBR System | Zavation Medical Products, LLC | Aug 6, 2019 | SESE |
| K183071 | VLIFT-s Vertebral Body Replacement System | Stryker Spine | Jan 10, 2019 | SESE |
| K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | Nov 20, 2018 | SESE |
| K173893 | Trabis | Coligne AG | Sep 6, 2018 | SESE |
| K180673 | Normandy VBR System | Zavation Medical Products, LLC | Jul 13, 2018 | SESE |
| K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | Nov 20, 2017 | SESE |
| K152568 | C-VBR | Cardinal Spine, LLC | Feb 11, 2016 | SESE |
| K151651 | NuVasive X-CORE Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | Sep 25, 2015 | SESE |
Top Applicants
- Zavation Medical Products, LLC — 2 clearances
- Nu Vasive, Incorporated — 2 clearances
- Bright Spine — 2 clearances
- Stryker Spine — 1 clearance
- Omnia Medical, LLC — 1 clearance
