Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nu Vasive, Incorporated — Predicate Candidate Screening
112 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
180 days90th percentile
112clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Sm | Nu Vasive, Incorporated | 2023-07-11 | 27 | 0 |
| K230894 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2023-06-16 | 77 | 0 |
| K230989 | Rod Registration Frame | Nu Vasive, Incorporated | 2023-05-05 | 29 | 0 |
| K223181 | NuVasive Reline System | Nu Vasive, Incorporated | 2023-01-11 | 92 | 0 |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Devic | Nu Vasive, Incorporated | 2022-10-21 | 127 | 0 |
| K221388 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | 2022-09-09 | 119 | 0 |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF | Nu Vasive, Incorporated | 2022-06-21 | 123 | 0 |
| K213654 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | 2022-02-23 | 96 | 0 |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent T | Nu Vasive, Incorporated | 2021-12-23 | 367 | 0 |
| K212446 | NuVasive Anterior Cervical Plate Systems | Nu Vasive, Incorporated | 2021-11-03 | 90 | 0 |
| K210574 | NuVasive Pulse System | Nu Vasive, Incorporated | 2021-07-29 | 153 | 1 |
| K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Inter | Nu Vasive, Incorporated | 2021-05-24 | 117 | 0 |
| K210439 | NuVasive MOD-EX XLIF Interbody System | Nu Vasive, Incorporated | 2021-05-12 | 89 | 0 |
| K210271 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2021-03-01 | 28 | 0 |
| K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolum | Nu Vasive, Incorporated | 2021-01-12 | 75 | 0 |
| K203253 | NuVasive ACP System | Nu Vasive, Incorporated | 2020-12-03 | 29 | 0 |
| K200719 | NuVasive Navigation.S Instruments | Nu Vasive, Incorporated | 2020-12-02 | 258 | 0 |
| K201692 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2020-10-29 | 129 | 0 |
| K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2020-10-06 | 180 | 0 |
| K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolum | Nu Vasive, Incorporated | 2020-09-25 | 86 | 0 |
| K200956 | NuVasive Thoracolumbar Plates | Nu Vasive, Incorporated | 2020-05-21 | 42 | 0 |
| K201078 | NuVasive® ACP System | Nu Vasive, Incorporated | 2020-05-20 | 28 | 0 |
| K193541 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2020-03-30 | 101 | 0 |
| K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020-03-25 | 93 | 0 |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini | Nu Vasive, Incorporated | 2020-02-26 | 70 | 0 |
| K192582 | NuVasive CoRoent Small Interlock System | Nu Vasive, Incorporated | 2019-11-13 | 55 | 0 |
| K191974 | NuVasive AttraX Putty | Nu Vasive, Incorporated | 2019-11-03 | 102 | 0 |
| K190636 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | 2019-10-19 | 221 | 0 |
| K192760 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2019-10-18 | 18 | 0 |
| K192435 | NuVasive NuvaLine | Nu Vasive, Incorporated | 2019-09-26 | 21 | 0 |
| K191500 | NuVasive® ACP System | Nu Vasive, Incorporated | 2019-09-03 | 89 | 0 |
| K191553 | NuVaisve® Reline® Cervical System | Nu Vasive, Incorporated | 2019-08-14 | 63 | 0 |
| K191169 | NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated | 2019-07-03 | 63 | 0 |
| K190418 | NuVasive® VersaTie® System | Nu Vasive, Incorporated | 2019-03-21 | 28 | 0 |
| K182974 | NuVasive Reline System | Nu Vasive, Incorporated | 2019-02-13 | 110 | 0 |
| K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018-11-28 | 275 | 0 |
| K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | 2018-11-20 | 264 | 0 |
| K181860 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2018-10-05 | 85 | 0 |
| K181386 | NuVasive Brigade Lateral System | Nu Vasive, Incorporated | 2018-08-24 | 91 | 0 |
| K180038 | NuVasive Pulse System | Nu Vasive, Incorporated | 2018-06-29 | 175 | 0 |
| K173892 | NuVasive® XLX Interbody System | Nu Vasive, Incorporated | 2018-05-04 | 134 | 0 |
| K180198 | NuVasive® VuePoint® II OCT System | Nu Vasive, Incorporated | 2018-03-15 | 50 | 0 |
| K173025 | NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody | Nu Vasive, Incorporated | 2018-02-08 | 133 | 0 |
| K172623 | NuVasive Navigation Instruments | Nu Vasive, Incorporated | 2017-12-21 | 111 | 0 |
| K172676 | NuVasive® Modulus-C Interbody System | Nu Vasive, Incorporated | 2017-12-14 | 100 | 0 |
| K173153 | Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion Syst | Nu Vasive, Incorporated | 2017-12-06 | 68 | 0 |
| K172497 | NuVasive AttraX Scaffold | Nu Vasive, Incorporated | 2017-11-24 | 98 | 0 |
| K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | Nu Vasive, Incorporated | 2017-11-21 | 54 | 0 |
| K173314 | LessRay System | Nu Vasive, Incorporated | 2017-11-16 | 28 | 0 |
| K172979 | NuVasive® Growth Rod Conversion Set | Nu Vasive, Incorporated | 2017-11-06 | 40 | 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