<?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>f9389833-bbf7-470b-a2e9-2944e93b258e</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-04-09</publicVersionDate><devicePublishDate>2024-04-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>05055662969887</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>COGNiTiON™ Staple System</brandName><versionModelNumber>OS380041-NS</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>218648211</dunsNumber><companyName>ORTHO SOLUTIONS HOLDINGS LIMITED</companyName><deviceCount>1</deviceCount><deviceDescription>COGNiTiON 1.9 X 60MM PIN</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>+441621843599</phone><phoneExtension xsi:nil="true"/><email>quality@orthosol.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>46479</gmdnCode><gmdnPTName>Surgical implant template, reusable</gmdnPTName><gmdnPTDefinition>A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HXB</productCode><productCodeName>Probe</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>