<?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>68180c16-967e-4327-8c60-67dae39047f8</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2025-07-02</publicVersionDate><devicePublishDate>2015-11-06</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00889095259124</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>PROTEX</brandName><versionModelNumber>109.372</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>139105691</dunsNumber><companyName>GLOBUS MEDICAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>7.0mm PROTEX Monoaxial Screw, 6.0mm Rod, 30mm</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+1(610)930-1800</phone><phoneExtension xsi:nil="true"/><email>info@globusmedical.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K040442</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>37272</gmdnCode><gmdnPTName>Trans-facet-screw internal spinal fixation system, sterile</gmdnPTName><gmdnPTDefinition>A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Obsolete</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MNH</productCode><productCodeName>Orthosis, spondylolisthesis spinal fixation</productCodeName></fdaProductCode><fdaProductCode><productCode>KWQ</productCode><productCodeName>APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY</productCodeName></fdaProductCode><fdaProductCode><productCode>KWP</productCode><productCodeName>APPLIANCE, FIXATION, SPINAL INTERLAMINAL</productCodeName></fdaProductCode><fdaProductCode><productCode>NKB</productCode><productCodeName>Orthosis, spinal pedicle fixation, for degenerative disc disease</productCodeName></fdaProductCode><fdaProductCode><productCode>MNI</productCode><productCodeName>ORTHOSIS, SPINAL PEDICLE FIXATION</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="7"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="30"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>