<?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>87cf83b8-134f-4032-b7ff-2577669f7381</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2019-08-01</publicVersionDate><devicePublishDate>2016-12-29</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>37613154687160</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>07613154687169</containsDINumber><pkgQuantity>2</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>pack</pkgType></identifier><identifier><deviceId>07613154687169</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>AutoPlex, VertaPlex</brandName><versionModelNumber>0605687000</versionModelNumber><catalogNumber>0605-687-000</catalogNumber><dunsNumber>196548481</dunsNumber><companyName>STRYKER CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>System without Needles with Bone Cement</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>false</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>+1(800)253-3210</phone><phoneExtension xsi:nil="true"/><email>Inst.Stryker.cs@Stryker.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>47742</gmdnCode><gmdnPTName>Orthopaedic cement mixing container, single-use</gmdnPTName><gmdnPTDefinition>A sterile device in which an orthopaedic cement dispenser is intended to be placed to maintain the sterility of the dispenser and its contents (orthopaedic cement) when it is taken out of the sterile field to be mixed by an automatic mixer during a surgical procedure. It is typically made of plastic material and designed to be passed by operating staff from the sterile field to staff who may not be sterile, and back again, without compromising the sterility of its contents. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LOD</productCode><productCodeName>BONE CEMENT</productCodeName></fdaProductCode><fdaProductCode><productCode>JDZ</productCode><productCodeName>MIXER, CEMENT, FOR CLINICAL USE</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="75"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="40"/><storageHandlingLow unit="Degrees Celsius" value="-20"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>