Home / 510(k) Clearances / K173526

510(k) K173526

SENTIO MMG Gen 2 by Medos International SARL — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2018
Date Received
November 14, 2017
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 Medos International SARL

  • K253249 — TriALTIS™ Spine System (October 21, 2025)
  • K243249 — TriALTIS™ Spine System (January 17, 2025)
  • K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (September 16, 2024)
  • K242042 — TriALTIS™ Spine System (September 9, 2024)
  • K233684 — TriALTIS™ Spine System (December 12, 2023)
  • K233366 — SYMPHONY OCT System (November 9, 2023)
  • K232492 — 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomp (October 6, 2023)
  • K231479 — TriALTIS Spine System (September 22, 2023)
  • K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications (February 10, 2023)
  • K223108 — TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear (January 19, 2023)

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)