<?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>84297e4d-0306-4a57-8e5f-a1a74312e3f1</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2025-02-06</publicVersionDate><devicePublishDate>2021-05-07</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10886982297549</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>NA</brandName><versionModelNumber>04.043.065S</versionModelNumber><catalogNumber>04043065S</catalogNumber><dunsNumber>486711679</dunsNumber><companyName>Synthes GmbH</companyName><deviceCount>1</deviceCount><deviceDescription>TIBIAL NAIL-ADVANCED / 8MM 435MM / STERILE</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>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)255-2500</phone><phoneExtension xsi:nil="true"/><email>xx@xx.xx</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K201336</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>38152</gmdnCode><gmdnPTName>Tibia intramedullary nail</gmdnPTName><gmdnPTDefinition>A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HWC</productCode><productCodeName>Screw, fixation, bone</productCodeName></fdaProductCode><fdaProductCode><productCode>JDS</productCode><productCodeName>NAIL, FIXATION, BONE</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>