510(k) Report

Devices descending from K002677

31 later devices reach Nuvasive Ins-1 Intraoperative Nerve Surveillance System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110140Neurovision Nerve Locator MonitorNeurovision Medical Products, Inc.20111—
+1K090838Stimulus/Dissection InstrumentsAxon Systems, Inc.200919—
+1K073229Nerve Monitoring CablePioneer Surgical Technology20085—
+1K030526Pediguard Nerve Detector SystemSpine Vision, Inc.20046—
+1K013215Modified Ins-1 Intraoperative Nerve Surveillance SystemNuvasive, Inc.20016—
+2K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+2K143159Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard…Spineguard S.A.20154—
+2K123390Pediguard Nerve Detector SystemSpineguard S.A.20135—
+2K121931Nondisposable Stimulating InstrumentsNeurovision Medical Products, Inc.20120—
+2K111597Disposable Stimulating ElectrodeNuvasive, Inc.201110—
+2K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine20119—
+2K110712Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc.20113—
+3K212164Mapping Suction ProbeInomed Medizintechnik GmbH20220—
+3K201454DSG Connect TechnologySpineguard S.A.20211—
+3K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+3K152747DSG Threaded Drill SystemSpineguard S.A.20163—
+3K133348Stim ProbeSpes Medica Srl201411
+3K140088Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC20142—
+3K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC)20145—
+3K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated20129—
+4K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.20231—
+4K222106Waypoint GPSWaypoint Orthopedics, Inc.20230—
+4K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+4K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+4K162884SpineGuard DSG Zavation Screw SystemSpineguard S.A.20172—
+4K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation20160—
+4K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+5K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…Tedan Surgical Innovations20260—
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302