Panels › Orthopedic › Product code PLR · Class 2
Spinal Vertebral Body Replacement Device - Cervical
Regulation 888.3060
2510(k)s in 12 months (19 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PLR
| Company | 510(k)s | Recalls |
|---|---|---|
| Atlas Spine, Inc. | 2 | 0 |
| Bright Spine | 2 | 0 |
| Nu Vasive, Incorporated | 2 | 0 |
| Zavation Medical Products, LLC | 2 | 0 |
| Aesculap Implants Systems, Inc. | 1 | 0 |
| Astura Medical, LLC | 1 | 0 |
| Cardinal Spine, LLC | 1 | 0 |
| Cmf Medicon Surgical, Inc. | 1 | 0 |
| Coligne AG | 1 | 0 |
| K2m, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2026 | K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant Atlas Spine, Inc. | PLR |
| Nov 10, 2025 | K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy System Atlas Spine, Inc. | PLR |
| Oct 13, 2023 | K232481 | RIGEL 3DR Anterior Cervical Corpectomy System MiRus, LLC | PLR |
| Jan 13, 2023 | K221542 | Galileo Vertebral Body Replacement Device Bright Spine | PLR |
| Apr 4, 2022 | K212126 | MediExpand Cervical Expandable VBR System Cmf Medicon Surgical, Inc. | PLR |
| Feb 24, 2022 | K211320 | CAPRI Corpectomy Cage System K2m, Inc. | PLR |
| Apr 21, 2020 | K192145 | Galileo Vertebral Body Replacement Device Bright Spine | PLR |
| Feb 24, 2020 | K193412 | NEXXT MATRIXX System Nexxt Spine, LLC | PLR |
| Dec 20, 2019 | K190284 | Bengal Stackable Cage System Medos International SARL, CH | PLR |
| Oct 24, 2019 | K190426 | ALTA Anterior Cervical Corpectomy System Astura Medical, LLC | PLR |
| Aug 28, 2019 | K191778 | Omnia Medical VBR Omnia Medical, LLC | PLR |
| Aug 6, 2019 | K191423 | Normandy VBR System Zavation Medical Products, LLC | PLR |
| Jan 10, 2019 | K183071 | VLIFT-s Vertebral Body Replacement System Stryker Spine | PLR |
| Nov 20, 2018 | K180550 | NuVasive Monolith Cervical Corpectomy System Nu Vasive, Incorporated | PLR |
| Sep 6, 2018 | K173893 | Trabis Coligne AG, CH | PLR |
| Jul 13, 2018 | K180673 | Normandy VBR System Zavation Medical Products, LLC | PLR |
| Nov 20, 2017 | K172032 | Modulift Vertebral Body Replacement (VBR) System Aesculap Implants Systems, Inc. | PLR |
| Feb 11, 2016 | K152568 | C-VBR Cardinal Spine, LLC | PLR |
| Sep 25, 2015 | K151651 | NuVasive X-CORE Mini Cervical Expandable VBR System Nu Vasive, Incorporated | PLR |
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