<?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>6a1b1cc9-c80f-46ac-b7ae-f89ea73e621d</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2018-09-28</publicVersionDate><devicePublishDate>2018-08-28</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M7402800007</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>Rampart O</brandName><versionModelNumber>83-04-07-13</versionModelNumber><catalogNumber>280-0007</catalogNumber><dunsNumber>033014361</dunsNumber><companyName>SPINEOLOGY INC.</companyName><deviceCount>1</deviceCount><deviceDescription>13x25mm Trial</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>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Unsafe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(651)256-8500</phone><phoneExtension>513</phoneExtension><email>kroche@spineology.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K160906</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61609</gmdnCode><gmdnPTName>Vertebral body bone graft pouch</gmdnPTName><gmdnPTDefinition>A sterile, implantable, mesh bag designed to contain and maintain the position of bone graft materials that have been implanted into a vertebral body defect, following bone tissue removal, to treat defects typically caused by trauma, deformity, tumours, or degenerative diseases. It is made of woven/knitted non-bioabsorbable synthetic polymer(s) material. Dedicated disposable devices associated with implantation may be included.</gmdnPTDefinition><implantable>true</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>13x25mm Trial</sizeText></deviceSize><deviceSize><sizeType>Height</sizeType><size unit="Millimeter" value="13"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>