<?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>aee00fc4-c4e7-4f79-b63c-4c7d413ee2a7</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-08-08</publicVersionDate><devicePublishDate>2022-07-29</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07630345717849</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>Hip Instruments</brandName><versionModelNumber>20.00002</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>488227125</dunsNumber><companyName>Medacta International SA</companyName><deviceCount>1</deviceCount><deviceDescription>AMIS Nozzle - Instrument  set EASYMIX</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</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/><gmdnTerms><gmdn><gmdnCode>47737</gmdnCode><gmdnPTName>Orthopaedic cement injection cannula</gmdnPTName><gmdnPTDefinition>A sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GEA</productCode><productCodeName>Cannula, Surgical, General &amp; Plastic Surgery</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>