Home / 510(k) Clearances / K143159

510(k) K143159

Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS by Spineguard S.A. — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2015
Date Received
November 3, 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.

Other clearances by Spineguard S.A.

  • K241895 — Cannulated PsiFGuard (September 26, 2024)
  • K220160 — PediGuard Threaded (March 31, 2022)
  • K201454 — DSG Connect Technology (February 10, 2021)
  • K162884 — SpineGuard DSG Zavation Screw System (January 12, 2017)
  • K152747 — DSG Threaded Drill System (June 10, 2016)
  • 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)
  • K220160 — PediGuard Threaded (March 31, 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)