<?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>ff35c7bf-9dc8-4391-8740-fc7a9c4efd33</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-11-21</publicVersionDate><devicePublishDate>2025-11-13</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>03662663154802</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>Zyston Interbody Spacer System</brandName><versionModelNumber>14-533015</versionModelNumber><catalogNumber>14-533015</catalogNumber><dunsNumber>119260394</dunsNumber><companyName>Highridge Medical, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>CURVE TRIAL 15HX27L 0 DEG</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>+1(800)447-3625</phone><phoneExtension xsi:nil="true"/><email>usbrocustomerservice@highridgemedical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>44788</gmdnCode><gmdnPTName>Spinal implant trial</gmdnPTName><gmdnPTDefinition>A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MAX</productCode><productCodeName>Intervertebral fusion device with bone graft, lumbar</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Device Size Text, specify---CURVE TRIAL 15HX27L 0 DEG 20 DEG ANGLE</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>