FDA.reportPublic FDA data

510(k) K223438

Device
TELIGEN System Peripheral Motor Nerve Stimulation Indications
Applicant
Medos International SARL
510(k) number
K223438
Product code
PDQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-10
Date received
2022-11-14
Regulation
874.1820
Classification name
Neurosurgical Nerve Locator
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Daria Bochenek
Address
Chemin Blanc 38 Le Locle CH 2400 2400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PDQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)Tedan Surgical Innovations2026-04-26
K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC2025-06-26
K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.2022-09-23
K220160PediGuard ThreadedSpineguard S.A.2022-03-31
K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.2021-03-17
K201454DSG Connect TechnologySpineguard S.A.2021-02-10
K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.2019-10-18
K190163ALARA Neuro Access KitSurGenTec, LLC2019-07-16
K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.2019-05-09
K182662NAV PAK Needle, NIM NAV PAK NeedleBoston Endo Surgical Tech,2019-04-10
K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.2018-11-09
K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech,2018-08-22
K173526SENTIO MMG Gen 2Medos International SARL2018-04-05
K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL2018-03-22
K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation2017-07-18