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510(k) K220160

PediGuard Threaded by Spineguard S.A. — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2022
Date Received
January 19, 2022
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 Spineguard S.A.

  • K241895 — Cannulated PsiFGuard (September 26, 2024)
  • K201454 — DSG Connect Technology (February 10, 2021)
  • K162884 — SpineGuard DSG Zavation Screw System (January 12, 2017)
  • K152747 — DSG Threaded Drill System (June 10, 2016)
  • K143159 — Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGua (January 23, 2015)
  • K123390 — PEDIGUARD NERVE DETECTOR SYSTEM (August 8, 2013)

Other clearances for product code PDQ

  • K243636 — Neuralytix iD3 System (NTX-9001) (June 26, 2025)
  • K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications (February 10, 2023)
  • K221821 — ATEC IOM Accessory Instruments (September 23, 2022)
  • K203684 — Neurosign V4 Intraoperative Nerve Monitor (March 17, 2021)
  • K201454 — DSG Connect Technology (February 10, 2021)
  • K191723 — ATEC IOM Accessory Instruments (October 18, 2019)
  • K190163 — ALARA Neuro Access Kit (July 16, 2019)
  • 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)