Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PLR — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
155 daysmedian FDA review time
312 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252822 | Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. | 2026-07-15 | 314 | 0 |
| K252560 | Atlas Spine HiRISE™ Expandable Cervical Corpectomy System | Atlas Spine, Inc. | 2025-11-10 | 89 | 0 |
| K232481 | RIGEL™ 3DR Anterior Cervical Corpectomy System | MiRus, LLC | 2023-10-13 | 58 | 0 |
| K221542 | Galileo Vertebral Body Replacement Device | Bright Spine | 2023-01-13 | 231 | 0 |
| K212126 | MediExpand Cervical Expandable VBR System | Cmf Medicon Surgical, Inc. | 2022-04-04 | 271 | 0 |
| K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022-02-24 | 300 | 0 |
| K192145 | Galileo Vertebral Body Replacement Device | Bright Spine | 2020-04-21 | 257 | 0 |
| K193412 | NEXXT MATRIXX System | Nexxt Spine, LLC | 2020-02-24 | 77 | 0 |
| K190284 | Bengal Stackable Cage System | Medos International SARL | 2019-12-20 | 312 | 0 |
| K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | 2019-10-24 | 244 | 0 |
| K191778 | Omnia Medical VBR | Omnia Medical, LLC | 2019-08-28 | 57 | 0 |
| K191423 | Normandy VBR System | Zavation Medical Products, LLC | 2019-08-06 | 69 | 0 |
| K183071 | VLIFT-s Vertebral Body Replacement System | Stryker Spine | 2019-01-10 | 66 | 0 |
| K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | 2018-11-20 | 264 | 0 |
| K173893 | Trabis | Coligne AG | 2018-09-06 | 259 | 0 |
| K180673 | Normandy VBR System | Zavation Medical Products, LLC | 2018-07-13 | 121 | 0 |
| K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017-11-20 | 138 | 0 |
| K152568 | C-VBR | Cardinal Spine, LLC | 2016-02-11 | 155 | 0 |
| K151651 | NuVasive X-CORE Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | 2015-09-25 | 99 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda