510(k) Report

Devices descending from K103128

17 later devices reach Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230853EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc.20231—
+1K132138Rhythmlink Disposable Concentric Stimulating ProbeRhythmlink International, LLC20143—
+1K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC)20145—
+1K112426Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd.20122—
+1K111597Disposable Stimulating ElectrodeNuvasive, Inc.201110—
+2K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC20240—
+2K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+2K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+2K133348Stim ProbeSpes Medica Srl201411
+2K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated20129—
+3K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+3K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+3K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+3K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation20160—
+3K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+4K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+4K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—