<?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>efa6ef34-aaca-4766-a031-f8738a0a3a35</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2025-07-02</publicVersionDate><devicePublishDate>2016-01-21</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M7256106540</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>TIGER Spine System</brandName><versionModelNumber>61065-40</versionModelNumber><catalogNumber>61065-40</catalogNumber><dunsNumber>064191453</dunsNumber><companyName>CORELINK LLC</companyName><deviceCount>1</deviceCount><deviceDescription>POSTED PEDICLE SCREW  - POLY-AXIAL - 6.5MM X 40MM</deviceDescription><DMExempt>false</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>+1(314)863-5401</phone><phoneExtension xsi:nil="true"/><email>customer.service@corelinksurgical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>61325</gmdnCode><gmdnPTName>Bone-screw internal spinal fixation system, non-sterile</gmdnPTName><gmdnPTDefinition>An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Obsolete</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><fdaProductCode><productCode>MNH</productCode><productCodeName>Orthosis, spondylolisthesis spinal fixation</productCodeName></fdaProductCode><fdaProductCode><productCode>NKB</productCode><productCodeName>Orthosis, spinal pedicle fixation, for degenerative disc disease</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="40"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="6.5"/><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>