<?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>3b69f1ee-ff42-4253-bd09-389bb7745041</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2018-03-29</publicVersionDate><devicePublishDate>2015-08-31</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M719GP3000</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>Apache</brandName><versionModelNumber>1</versionModelNumber><catalogNumber>GP300</catalogNumber><dunsNumber>017921066</dunsNumber><companyName>Genesys Orthopedics Systems LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Straight Tamp</deviceDescription><DMExempt>true</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</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>512-381-7070</phone><phoneExtension xsi:nil="true"/><email>info@genesysspine.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>57806</gmdnCode><gmdnPTName>Vertebral body prosthesis, non-sterile</gmdnPTName><gmdnPTDefinition>A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Obsolete</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ODP</productCode><productCodeName>Intervertebral Fusion Device With Bone Graft, Cervical</productCodeName></fdaProductCode><fdaProductCode><productCode>MQP</productCode><productCodeName>Spinal Vertebral Body Replacement Device</productCodeName></fdaProductCode><fdaProductCode><productCode>MAX</productCode><productCodeName>Intervertebral Fusion Device With Bone Graft, Lumbar</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>