<?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>c2801890-083d-4263-ab85-9bd97a8403b1</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-04-19</publicVersionDate><devicePublishDate>2022-04-11</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>04946329068696</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>Leg Traction Device</brandName><versionModelNumber>08-115-11</versionModelNumber><catalogNumber>08-115-11</catalogNumber><dunsNumber>690677802</dunsNumber><companyName>MIZUHO CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>Inner Thigh Support with Pad for Traction in Lateral Posture</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>true</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>9999999999</phone><phoneExtension xsi:nil="true"/><email>regulatory@mizuho.co.jp</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>46511</gmdnCode><gmdnPTName>Surgical traction tensioner</gmdnPTName><gmdnPTDefinition>A hand-operated tensioning device designed to be attached to a patient-contact device (e.g., hand wrap/trap, pelvic bone pin, foot boot, skull tongs) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis), typically during orthopaedic procedures (e.g., cervical spine surgery, pelvic reconstruction, fracture reduction). It may be a floor-standing pole or attached to an operating table or table extension, and typically consists of a multi-jointed structure with metal bars/posts, a manual screw/crank for traction adjustment, and mounting clamps/adaptors.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GDC</productCode><productCodeName>Table, Operating-Room, Electrical</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="352"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>