NIM Vital, Nerve Integrity Monitor
FDA 510(k) K200759 · Medtronic Xomed, Inc.
510(k) numberK200759
Submission
- Device name
- NIM Vital, Nerve Integrity Monitor
- Applicant
- Medtronic Xomed, Inc.
Jacksonville, FL, US - Received
- March 24, 2020
- Decision date
- October 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GWF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253301 | BraiN20® (BraiN20)GWF · Traditional | Time IS Brain, S.L. | 06/27/2026SE |
| K252842 | SafeOp 3: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 01/11/2026SE |
| K243982 | Nicolet EDXGWF · Special | Natus Neurology Incorporated | 01/22/2025SE |
| K243495 | Natus Ultrapro S100 (982A0594)GWF · Special | Natus Neurology Incorporated | 12/12/2024SE |
| K242345 | Delphi StimulatorGWF · Traditional | Quantalx Neuroscience | 11/05/2024SE |
| K234092 | SafeOp 3: Neural Informatix SysteemGWF · Traditional | Alphatec Spine, Inc. | 04/19/2024SE |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional | Soterix Medical, Inc. | 03/25/2024SE |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special | Inomed Medizintechnik GmbH | 10/27/2023SE |
| K230415 | Cadwell GuardianGWF · Traditional | Cadwell Industries, Inc. | 08/17/2023SE |
| K213849 | SafeOp 2: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 03/09/2022SE |
More from Alphatec Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated…PGW · Traditional | 09/04/2026SE |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube…ETN · Traditional | 02/10/2026SE |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN · Special | 10/26/2023SE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN · Traditional | 08/30/2023SE |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM…ETN · Traditional | 03/21/2022SE |
| K210841 | NuVent Eustachian Tube Dilation BalloonPNZ · Traditional | 08/16/2021SE |
| K202623 | Novapak Nasal Sinus Packing and StentLYA · Traditional | 12/08/2020SE |
| K173855 | Sharpsite AC Rigid EndsocopeEOB · Traditional | 04/20/2018SE |
| K152121 | NuVent EM Sinus Dilation SystemLRC · Traditional | 12/01/2015SE |
| K151758 | ALAR Nasal Valve StentGAT · Traditional | 10/29/2015SE |
Questions and answers
When was NIM Vital, Nerve Integrity Monitor cleared by the FDA?
NIM Vital, Nerve Integrity Monitor (K200759) received a 510(k) decision of Substantially Equivalent on October 28, 2020, 218 days after the submission was received.
What is the product code of K200759?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.