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510(k) K203684

Neurosign V4 Intraoperative Nerve Monitor by Magstim Company, Ltd. — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2021
Date Received
December 17, 2020
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.

Other clearances by Magstim Company, Ltd.

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  • K222171 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, H (January 13, 2023)
  • K211389 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon (September 14, 2021)
  • K183376 — HORIZON TMS Therapy System with Navigation (April 3, 2019)
  • K182853 — HORIZON TMS Therapy System (March 15, 2019)
  • K181559 — Neurosign V4 Intraoperative Nerve Monitor (November 9, 2018)
  • K180907 — HORIZON TMS Therapy System (August 3, 2018)
  • K171051 — HORIZON Therapy System (September 13, 2017)
  • K162935 — Rapid2 Therapy System (March 10, 2017)

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  • K201454 — DSG Connect Technology (February 10, 2021)
  • K191723 — ATEC IOM Accessory Instruments (October 18, 2019)
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  • K182617 — ATEC IOM Accessory Instruments (May 9, 2019)
  • K182662 — NAV PAK Needle, NIM NAV PAK Needle (April 10, 2019)
  • K181559 — Neurosign V4 Intraoperative Nerve Monitor (November 9, 2018)