<?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>bab45566-ddcd-4fd3-ab0b-89b35cf69613</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>8</publicVersionNumber><publicVersionDate>2025-10-24</publicVersionDate><devicePublishDate>2015-09-24</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10889981043391</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>Sierra™</brandName><versionModelNumber>50-7044</versionModelNumber><catalogNumber>50-7044</catalogNumber><dunsNumber>079840876</dunsNumber><companyName>Seaspine Orthopedics Corporation</companyName><deviceCount>1</deviceCount><deviceDescription>Sierra Lag Screw, 03.5 x 44mm</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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(760)727-8399</phone><phoneExtension xsi:nil="true"/><email>custsvcspine@seaspine.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K062934</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61235</gmdnCode><gmdnPTName>Cannulated surgical drill bit, single-use</gmdnPTName><gmdnPTDefinition>A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KWP</productCode><productCodeName>APPLIANCE, FIXATION, SPINAL INTERLAMINAL</productCodeName></fdaProductCode><fdaProductCode><productCode>MNI</productCode><productCodeName>ORTHOSIS, SPINAL PEDICLE FIXATION</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>3.5  Dia X  44mm</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>