FDA Product Code PDQ: Neurosurgical Nerve Locator
To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
Leading manufacturers include Alphatec Spine, Inc., Medos International SARL and Neuralytix, LLC.
FDA 510(k) Cleared Neurosurgical Nerve Locator Devices (Product Code PDQ)
About Product Code PDQ - Regulatory Context
510(k) Submission Activity
35 total 510(k) submissions under product code PDQ since 2013, with 35 receiving FDA clearance (average review time: 177 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
FDA review times for PDQ submissions have been consistent, averaging 187 days recently vs 176 days historically.
PDQ devices are reviewed by the Neurology panel. Browse all Neurology devices →