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510(k) K171807

ES2 Neuromonitoring Accessory Instruments by Stryker Corporation — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2017
Date Received
June 19, 2017
Clearance Type
Special
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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