<?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>9926a3f6-05e5-4cee-a2c3-423c38798733</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-11-24</publicVersionDate><devicePublishDate>2025-11-16</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>03662663069458</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>Mergence-S Spinal Instrumentation System</brandName><versionModelNumber>96-105-10001</versionModelNumber><catalogNumber>96-105-10001</catalogNumber><dunsNumber>119260394</dunsNumber><companyName>Highridge Medical, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Central Tamp</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</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><customerContact><phone>+1(800)447-3625</phone><phoneExtension xsi:nil="true"/><email>usbrocustomerservice@highridgemedical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>32873</gmdnCode><gmdnPTName>Surgical tamp, reusable</gmdnPTName><gmdnPTDefinition>A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ODP</productCode><productCodeName>Intervertebral fusion device with bone graft, cervical</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>