Company · US
Nu Vasive, Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2023. Name variants (Inc, Corp, punctuation) are merged.
112510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 34 |
| NKB | Thoracolumbosacral Pedicle Screw System | 10 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 8 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 |
| NKG | Posterior Cervical Screw System | 6 |
| MQP | Spinal Vertebral Body Replacement Device | 5 |
| OLO | Orthopedic Stereotaxic Instrument | 5 |
| PDQ | Neurosurgical Nerve Locator | 5 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 |
| LLZ | System, Image Processing, Radiological | 2 |
| MQV | Filler, Bone Void, Calcium Compound | 2 |
| OWB | Interventional Fluoroscopic X-Ray System | 2 |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 |
| PEK | Spinous Process Plate | 2 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 2 |
| ETN | Stimulator, Nerve | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 |
| PGM | Growing Rod System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 2023 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Inter Nu Vasive, Incorporated | ODP |
| Jun 16, 2023 | K230894 | NuVasive Modulus ALIF System Nu Vasive, Incorporated | OVD |
| May 5, 2023 | K230989 | Rod Registration Frame Nu Vasive, Incorporated | OLO |
| Jan 11, 2023 | K223181 | NuVasive Reline System Nu Vasive, Incorporated | NKB |
| Oct 21, 2022 | K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device Nu Vasive, Incorporated | OVD |
| Sep 9, 2022 | K221388 | NuVasive Reline Cervical System Nu Vasive, Incorporated | NKG |
| Jun 21, 2022 | K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System Nu Vasive, Incorporated | MAX |
| Feb 23, 2022 | K213654 | NuVasive Reline Cervical System Nu Vasive, Incorporated | NKG |
| Dec 23, 2021 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System Nu Vasive, Incorporated | MAX |
| Nov 3, 2021 | K212446 | NuVasive Anterior Cervical Plate Systems Nu Vasive, Incorporated | KWQ |
| Jul 29, 2021 | K210574 | NuVasive Pulse System Nu Vasive, Incorporated | OLO |
| May 24, 2021 | K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Nu Vasive, Incorporated | MAX |
| May 12, 2021 | K210439 | NuVasive MOD-EX XLIF Interbody System Nu Vasive, Incorporated | MAX |
| Mar 1, 2021 | K210271 | NuVasive Modulus ALIF System Nu Vasive, Incorporated | OVD |
| Jan 12, 2021 | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlor Nu Vasive, Incorporated | MAX |
| Dec 3, 2020 | K203253 | NuVasive ACP System Nu Vasive, Incorporated | KWQ |
| Dec 2, 2020 | K200719 | NuVasive Navigation.S Instruments Nu Vasive, Incorporated | OLO |
| Oct 29, 2020 | K201692 | NuVasive Modulus XLIF Interbody System Nu Vasive, Incorporated | MAX |
| Oct 6, 2020 | K200953 | NuVasive® Cohere® Thoracolumbar Interbody System Nu Vasive, Incorporated | MAX |
| Sep 25, 2020 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalo Nu Vasive, Incorporated | MAX |
| May 21, 2020 | K200956 | NuVasive Thoracolumbar Plates Nu Vasive, Incorporated | KWQ |
| May 20, 2020 | K201078 | NuVasive® ACP System Nu Vasive, Incorporated | KWQ |
| Mar 30, 2020 | K193541 | NuVasive Cohere Thoracolumbar Interbody System Nu Vasive, Incorporated | MAX |
| Mar 25, 2020 | K193593 | NuVasive 3DP Interfixated ALIF System Nu Vasive, Incorporated | OVD |
| Feb 26, 2020 | K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System Nu Vasive, Incorporated | MQP |
| Nov 13, 2019 | K192582 | NuVasive CoRoent Small Interlock System Nu Vasive, Incorporated | OVE |
| Nov 3, 2019 | K191974 | NuVasive AttraX Putty Nu Vasive, Incorporated | MQV |
| Oct 19, 2019 | K190636 | NuVasive® Reline® 4.5-5.0 System Nu Vasive, Incorporated | NKB |
| Oct 18, 2019 | K192760 | NuVasive Modulus XLIF Interbody System Nu Vasive, Incorporated | MAX |
| Sep 26, 2019 | K192435 | NuVasive NuvaLine Nu Vasive, Incorporated | LLZ |
| Sep 3, 2019 | K191500 | NuVasive® ACP System Nu Vasive, Incorporated | KWQ |
| Aug 14, 2019 | K191553 | NuVaisve® Reline® Cervical System Nu Vasive, Incorporated | NKG |
| Jul 3, 2019 | K191169 | NuVasive® Camber Laminoplasty System Nu Vasive, Incorporated | NQW |
| Mar 21, 2019 | K190418 | NuVasive® VersaTie® System Nu Vasive, Incorporated | OWI |
| Feb 13, 2019 | K182974 | NuVasive Reline System Nu Vasive, Incorporated | NKB |
| Nov 28, 2018 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement Nu Vasive, Incorporated | PML |
| Nov 20, 2018 | K180550 | NuVasive Monolith Cervical Corpectomy System Nu Vasive, Incorporated | PLR |
| Oct 5, 2018 | K181860 | NuVasive Cohere Thoracolumbar Interbody System Nu Vasive, Incorporated | MAX |
| Aug 24, 2018 | K181386 | NuVasive Brigade Lateral System Nu Vasive, Incorporated | OVD |
| Jun 29, 2018 | K180038 | NuVasive Pulse System Nu Vasive, Incorporated | OLO |
| May 4, 2018 | K173892 | NuVasive® XLX Interbody System Nu Vasive, Incorporated | MAX |
| Mar 15, 2018 | K180198 | NuVasive® VuePoint® II OCT System Nu Vasive, Incorporated | NKG |
| Feb 8, 2018 | K173025 | NuVasive® MLX® Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System Nu Vasive, Incorporated | MAX |
| Dec 21, 2017 | K172623 | NuVasive Navigation Instruments Nu Vasive, Incorporated | OLO |
| Dec 14, 2017 | K172676 | NuVasive® Modulus-C Interbody System Nu Vasive, Incorporated | ODP |
| Dec 6, 2017 | K173153 | Vertera Spine Coalesce Thoracolumbar Interbody Fusion System Nu Vasive, Incorporated | MAX |
| Nov 24, 2017 | K172497 | NuVasive AttraX Scaffold Nu Vasive, Incorporated | MQV |
| Nov 21, 2017 | K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device Nu Vasive, Incorporated | ODP |
| Nov 16, 2017 | K173314 | LessRay System Nu Vasive, Incorporated | OWB |
| Nov 6, 2017 | K172979 | NuVasive® Growth Rod Conversion Set Nu Vasive, Incorporated | PGM |
Newest 50 of 112.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||