<?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>a9dc0b67-f654-4fb8-a8d7-bbd55bb2a0d7</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2023-04-03</publicVersionDate><devicePublishDate>2021-09-16</devicePublishDate><deviceCommDistributionEndDate>2023-03-16</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B562OGSPDG20</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Exact Osteotomy System</brandName><versionModelNumber>OGS-PDG2</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>062355158</dunsNumber><companyName>Wishbone Medical, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>EXACT OSTEOTOMY SYSTEM - PASA/DMAA (2-STAGE GUIDE)</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>false</manufacturingDate><expirationDate>true</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/><gmdnTerms><gmdn><gmdnCode>65079</gmdnCode><gmdnPTName>Osteotomy guide, single-use</gmdnPTName><gmdnPTDefinition>A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FZX</productCode><productCodeName>Guide, Surgical, Instrument</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>