<?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>a8a5af7c-9f09-4ea1-a719-3f45d12b8013</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>6</publicVersionNumber><publicVersionDate>2023-05-03</publicVersionDate><devicePublishDate>2016-08-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00850231007152</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>N/A</brandName><versionModelNumber>II-1-0015</versionModelNumber><catalogNumber>II-1-0015</catalogNumber><dunsNumber>080300717</dunsNumber><companyName>Integrity Implants Inc.</companyName><deviceCount>1</deviceCount><deviceDescription> Guide Pin Wrench
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</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>true</rx><otc>false</otc><contacts><customerContact><phone>8002019300</phone><phoneExtension xsi:nil="true"/><email>customerservice@integrityimplants.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>47847</gmdnCode><gmdnPTName>Orthopaedic implant-instrument extension adaptor, reusable</gmdnPTName><gmdnPTDefinition>A connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LXH</productCode><productCodeName>Orthopedic Manual Surgical Instrument</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>