<?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>91c96a09-ed0f-4d62-aa15-2827899c33a9</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2026-01-08</publicVersionDate><devicePublishDate>2022-03-31</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M711LS1750</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 II®</brandName><versionModelNumber>LS-175</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>141620464</dunsNumber><companyName>INNO Holdings, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>Radel, Silicone, SST
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</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>32871</gmdnCode><gmdnPTName>Surgical torque wrench, reusable</gmdnPTName><gmdnPTDefinition>A hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NKB</productCode><productCodeName>Thoracolumbosacral Pedicle Screw System</productCodeName></fdaProductCode><fdaProductCode><productCode>MNI</productCode><productCodeName>Orthosis, Spinal Pedicle Fixation</productCodeName></fdaProductCode><fdaProductCode><productCode>MNH</productCode><productCodeName>Orthosis, Spondylolisthesis Spinal Fixation</productCodeName></fdaProductCode><fdaProductCode><productCode>KWP</productCode><productCodeName>Appliance, Fixation, Spinal Interlaminal</productCodeName></fdaProductCode><fdaProductCode><productCode>KWQ</productCode><productCodeName>Appliance, Fixation, Spinal Intervertebral Body</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>