Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060) → PLR — Spinal Vertebral Body Replacement Device - Cervical # PLR · Spinal Vertebral Body Replacement Device - Cervical _Orthopedic · 21 CFR 888.3060 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR ## Overview - **Product Code:** PLR - **Device Name:** Spinal Vertebral Body Replacement Device - Cervical - **Regulation:** [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **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. ## Recent Cleared Devices (18 of 18) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252560](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K252560.md) | Atlas Spine HiRISE™ Expandable Cervical Corpectomy System | Atlas Spine, Inc. | Nov 10, 2025 | SESE | | [K232481](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K232481.md) | RIGEL™ 3DR Anterior Cervical Corpectomy System | MiRus, LLC | Oct 13, 2023 | SESE | | [K221542](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K221542.md) | Galileo Vertebral Body Replacement Device | Bright Spine | Jan 13, 2023 | SESE | | [K212126](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K212126.md) | MediExpand Cervical Expandable VBR System | Cmf Medicon Surgical, Inc. | Apr 4, 2022 | SESE | | [K211320](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K211320.md) | CAPRI Corpectomy Cage System | K2m, Inc. | Feb 24, 2022 | SESE | | [K192145](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K192145.md) | Galileo Vertebral Body Replacement Device | Bright Spine | Apr 21, 2020 | SESE | | [K193412](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K193412.md) | NEXXT MATRIXX System | Nexxt Spine, LLC | Feb 24, 2020 | SESE | | [K190284](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K190284.md) | Bengal Stackable Cage System | Medos International SARL | Dec 20, 2019 | SESE | | [K190426](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K190426.md) | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | Oct 24, 2019 | SESE | | [K191778](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K191778.md) | Omnia Medical VBR | Omnia Medical, LLC | Aug 28, 2019 | SESE | | [K191423](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K191423.md) | Normandy VBR System | Zavation Medical Products, LLC | Aug 6, 2019 | SESE | | [K183071](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K183071.md) | VLIFT-s Vertebral Body Replacement System | Stryker Spine | Jan 10, 2019 | SESE | | [K180550](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K180550.md) | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | Nov 20, 2018 | SESE | | [K173893](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K173893.md) | Trabis | Coligne AG | Sep 6, 2018 | SESE | | [K180673](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K180673.md) | Normandy VBR System | Zavation Medical Products, LLC | Jul 13, 2018 | SESE | | [K172032](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K172032.md) | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | Nov 20, 2017 | SESE | | [K152568](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K152568.md) | C-VBR | Cardinal Spine, LLC | Feb 11, 2016 | SESE | | [K151651](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR/K151651.md) | NuVasive X-CORE Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | Sep 25, 2015 | SESE | ## Top Applicants - Bright Spine — 2 clearances - Nu Vasive, Incorporated — 2 clearances - Zavation Medical Products, LLC — 2 clearances - Aesculap Implants Systems, Inc. — 1 clearance - Astura Medical, LLC — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PLR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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