Medical device manufacturer
Nu Vasive, Incorporated
Nu Vasive, Incorporated holds 112 FDA 510(k) clearances across 22 product codes. Median elapsed review time is 98 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 112
- Product codes
- 22
- Median review
- 98 days
- Recall records
- 0
How does FDA spell Nu Vasive, Incorporated?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Nu Vasive, Incorporated file in?
22 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 34 | 115 days | |
| NKB | Thoracolumbosacral Pedicle Screw System | 10 | 92 days | |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 10 | 77 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 8 | 93 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 | 42 days | |
| NKG | Posterior Cervical Screw System | 6 | 63 days | |
| MQP | Spinal Vertebral Body Replacement Device | 5 | 88 days | |
| OLO | Orthopedic Stereotaxic Instrument | 5 | 153 days | |
| PDQ | Neurosurgical Nerve Locator | 5 | 168 days | |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 | 69 days | |
| LLZ | System, Image Processing, Radiological | 2 | 21 days | |
| MQV | Filler, Bone Void, Calcium Compound | 2 | 98 days | |
| OWB | Interventional Fluoroscopic X-Ray System | 2 | 28 days | |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 | 28 days | |
| PEK | Spinous Process Plate | 2 | 99 days | |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 2 | 99 days | |
| ETN | Stimulator, Nerve | 1 | 143 days | |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 253 days | |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 | 63 days | |
| PGM | Growing Rod System | 1 | 40 days | |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | 1 | 63 days | |
| PML | Bone Cement, Posterior Screw Augmentation | 1 | 275 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Nu Vasive, Incorporated had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Nu Vasive, Incorporated cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | ODP | 27 | |
| K230894 | NuVasive Modulus ALIF System | OVD | 77 | |
| K230989 | Rod Registration Frame | OLO | 29 | |
| K223181 | NuVasive Reline System | NKB | 92 | |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device | OVD | 127 | |
| K221388 | NuVasive Reline Cervical System | NKG | 119 | |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | MAX | 123 | |
| K213654 | NuVasive Reline Cervical System | NKG | 96 | |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | MAX | 367 | |
| K212446 | NuVasive Anterior Cervical Plate Systems | KWQ | 90 |
Source: openFDA device/510k · retrieved
Watch what Nu Vasive, Incorporated files next
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