510(k) Report

Devices descending from K111597

10 later devices reach Disposable Stimulating Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated20129—
+2K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+2K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC)20145—
+2K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+3K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+3K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302