<?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>5bdba30f-70ba-4fe7-b576-7a6762b3db3f</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2026-02-09</publicVersionDate><devicePublishDate>2021-07-20</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00749756863025</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>DeRoyal</brandName><versionModelNumber>11-557A-02</versionModelNumber><catalogNumber>11-557A-02</catalogNumber><dunsNumber>096372255</dunsNumber><companyName>DEROYAL INDUSTRIES, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>KNEE BRACE, FUNCTIONAL ACL</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</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>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(888)938-7828</phone><phoneExtension xsi:nil="true"/><email>udisupport@deroyal.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>12099</gmdnCode><gmdnPTName>Knee splint</gmdnPTName><gmdnPTDefinition>A rigid, non-articulating, external support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ITQ</productCode><productCodeName>JOINT, KNEE, EXTERNAL BRACE</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>