510(k) Report

Devices descending from K063729

19 later devices reach Disposable Pedicle Screw Probe, Model 3603-00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc.201117—
+1K073229Nerve Monitoring CablePioneer Surgical Technology20085—
+2K230853EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc.20231—
+2K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+2K132138Rhythmlink Disposable Concentric Stimulating ProbeRhythmlink International, LLC20143—
+2K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC)20145—
+2K112426Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd.20122—
+2K111597Disposable Stimulating ElectrodeNuvasive, Inc.201110—
+3K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC20240—
+3K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+3K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+3K133348Stim ProbeSpes Medica Srl201411
+3K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated20129—
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+4K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation20160—
+4K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—