<?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>f1ad818a-790c-4acb-8b91-7f337b7632a5</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>6</publicVersionNumber><publicVersionDate>2026-01-08</publicVersionDate><devicePublishDate>2018-01-31</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M711LS1890</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>Excella MIS®</brandName><versionModelNumber>LS-189</versionModelNumber><catalogNumber>LS-189</catalogNumber><dunsNumber>141620464</dunsNumber><companyName>INNO Holdings, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>Nitinol
</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>801-261-2236</phone><phoneExtension xsi:nil="true"/><email>info@innovasis.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>63819</gmdnCode><gmdnPTName>Spinal guidewire</gmdnPTName><gmdnPTDefinition>A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KWQ</productCode><productCodeName>Appliance, Fixation, Spinal Intervertebral Body</productCodeName></fdaProductCode><fdaProductCode><productCode>KWP</productCode><productCodeName>Appliance, Fixation, Spinal Interlaminal</productCodeName></fdaProductCode><fdaProductCode><productCode>MNH</productCode><productCodeName>Orthosis, Spondylolisthesis Spinal Fixation</productCodeName></fdaProductCode><fdaProductCode><productCode>MNI</productCode><productCodeName>Orthosis, Spinal Pedicle Fixation</productCodeName></fdaProductCode><fdaProductCode><productCode>NKB</productCode><productCodeName>Thoracolumbosacral Pedicle Screw System</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="1.2"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="500"/><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>