<?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>ce311f3c-06e0-4625-8bb3-77b69a0468f7</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2017-02-25</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08033390109628</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>SMR Shoulder</brandName><versionModelNumber>Bone Graft Instrument Set</versionModelNumber><catalogNumber>9013.75.479</catalogNumber><dunsNumber>432066322</dunsNumber><companyName>LIMACORPORATE SPA</companyName><deviceCount>1</deviceCount><deviceDescription>Bone Graft Instrument Set - Reamer for Graft Shaping
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</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/><premarketSubmissions><premarketSubmission><submissionNumber>K161120</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>60927</gmdnCode><gmdnPTName>Glenoid orthopaedic reamer</gmdnPTName><gmdnPTDefinition>An orthopaedic surgical instrument designed to cut and resurface with precision the glenoid fossa for the acceptance of the glenoid fossa component of a shoulder joint prosthesis. The device is designed with a hemispherical head with an abrasive/cutting outer surface attached to a shaft for connection to a manual or powered handle. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device intended to be sterilized prior to use.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>PHX</productCode><productCodeName>Shoulder Prosthesis, Reverse Configuration</productCodeName></fdaProductCode><fdaProductCode><productCode>KWT</productCode><productCodeName>Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented</productCodeName></fdaProductCode><fdaProductCode><productCode>KWS</productCode><productCodeName>Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>