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510(k) K162313

NuVasive Next Generation NVM5 System by Nu Vasive, Incorporated — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2017
Date Received
August 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Nerve Locator
Device Class
Class II
Regulation Number
874.1820
Review Panel
NE
Submission Type

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

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