<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>c982301d-7092-4308-b16e-666cf5243512</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2025-06-11</publicVersionDate><devicePublishDate>2019-11-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00887517213402</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Remote Monitoring</brandName><versionModelNumber>8065010</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>053950783</dunsNumber><companyName>Nuvasive, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>Multimodality IOM Kit</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1800-475-9131</phone><phoneExtension xsi:nil="true"/><email>nuvainfo@globusmedical.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K143641</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>46566</gmdnCode><gmdnPTName>Neurophysiologic monitoring system</gmdnPTName><gmdnPTDefinition>An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HAW</productCode><productCodeName>Neurological stereotaxic Instrument</productCodeName></fdaProductCode><fdaProductCode><productCode>GWF</productCode><productCodeName>STIMULATOR, ELECTRICAL, EVOKED RESPONSE</productCodeName></fdaProductCode><fdaProductCode><productCode>IKN</productCode><productCodeName>Electromyograph, diagnostic</productCodeName></fdaProductCode><fdaProductCode><productCode>OLO</productCode><productCodeName>Orthopedic stereotaxic instrument</productCodeName></fdaProductCode><fdaProductCode><productCode>ETN</productCode><productCodeName>STIMULATOR, NERVE</productCodeName></fdaProductCode><fdaProductCode><productCode>PDQ</productCode><productCodeName>Neurosurgical nerve locator</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>