FDA Product Code
FDA Product Code PLR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3060
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. | 2026-07-15 | Traditional | PDF ↗ |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy System | Atlas Spine, Inc. | 2025-11-10 | Traditional | PDF ↗ |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy System | MiRus, LLC | 2023-10-13 | Traditional | PDF ↗ |
| K221542 | Galileo Vertebral Body Replacement Device | Bright Spine | 2023-01-13 | Special | PDF ↗ |
| K212126 | MediExpand Cervical Expandable VBR System | Cmf Medicon Surgical, Inc. | 2022-04-04 | Traditional | PDF ↗ |
| K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022-02-24 | Traditional | PDF ↗ |
| K192145 | Galileo Vertebral Body Replacement Device | Bright Spine | 2020-04-21 | Traditional | PDF ↗ |
| K193412 | NEXXT MATRIXX System | Nexxt Spine, LLC | 2020-02-24 | Traditional | PDF ↗ |
| K190284 | Bengal Stackable Cage System | Medos International SARL | 2019-12-20 | Traditional | PDF ↗ |
| K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | 2019-10-24 | Traditional | PDF ↗ |
| K191778 | Omnia Medical VBR | Omnia Medical, LLC | 2019-08-28 | Special | PDF ↗ |
| K191423 | Normandy VBR System | Zavation Medical Products, LLC | 2019-08-06 | Traditional | PDF ↗ |
| K183071 | VLIFT-s Vertebral Body Replacement System | Stryker Spine | 2019-01-10 | Special | PDF ↗ |
| K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | 2018-11-20 | Traditional | PDF ↗ |
| K173893 | Trabis | Coligne AG | 2018-09-06 | Traditional | PDF ↗ |
| K180673 | Normandy VBR System | Zavation Medical Products, LLC | 2018-07-13 | Traditional | PDF ↗ |
| K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017-11-20 | Traditional | PDF ↗ |
| K152568 | C-VBR | Cardinal Spine, LLC | 2016-02-11 | Traditional | PDF ↗ |
| K151651 | NuVasive X-CORE Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | 2015-09-25 | Traditional | PDF ↗ |
Product code PLR · Class II · Orthopedic. Data: openFDA.