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510(k) K143641

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2015
Date Received
December 22, 2014
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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