NuVasive NVM5 System— 510(k) K143641

Substantially Equivalent

Nu Vasive, Incorporated

FDA 510(k) clearance K143641 for NuVasive NVM5 System, Substantially Equivalent on 2015-03-27. Applicant: Nu Vasive, Incorporated. Device class: 2.

Clearance details

Applicant: Nu Vasive, Incorporated
Product code: Code PDQ
Device class: Class 2
Regulation: 21 CFR 874.1820
Advisory panel: Ear, Nose, Throat
Date received: 2014-12-22
Decision date: 2015-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PDQ

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Recalls naming K143641

K-number listed on FDA's recall record

Z-2684-2020 — Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.Class II·Terminated·NuVasive Inc·20200610

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143641.

Data sourced from openFDA. This site is unofficial and independent of the FDA.