<?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>b99f74e8-89c1-4e56-9b98-90e5003955d7</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2020-02-24</publicVersionDate><devicePublishDate>2015-10-27</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00889095217841</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>FORTIFY</brandName><versionModelNumber>351.381</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>139105691</dunsNumber><companyName>GLOBUS MEDICAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>FORTIFY-R 14mm Lower Endplate, 16x20mm Footprint, 0deg</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>K112756</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>34170</gmdnCode><gmdnPTName>Vertebral body prosthesis</gmdnPTName><gmdnPTDefinition>An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MQP</productCode><productCodeName>SPINAL VERTEBRAL BODY REPLACEMENT DEVICE</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="20"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Depth</sizeType><size unit="Millimeter" value="16"/><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>