<?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>fc5cebfe-57a8-46a6-b131-58fe17f8c851</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2024-09-11</publicVersionDate><devicePublishDate>2019-03-25</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00193082014246</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>APEX Spine System</brandName><versionModelNumber>P6-6280</versionModelNumber><catalogNumber>P6-6280</catalogNumber><dunsNumber>783908713</dunsNumber><companyName>SPINECRAFT, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>APEX Ti Poly Screw Dia.6.25, 80mm</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>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(630)920-7300</phone><phoneExtension xsi:nil="true"/><email>info@spinecraft.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K062513</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>K092825</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>K102488</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>K110906</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>K132603</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>46651</gmdnCode><gmdnPTName>Spinal bone screw, non-bioabsorbable</gmdnPTName><gmdnPTDefinition>A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.</gmdnPTDefinition><implantable>true</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><fdaProductCode><productCode>MNH</productCode><productCodeName>Orthosis, spondylolisthesis spinal fixation</productCodeName></fdaProductCode><fdaProductCode><productCode>KWQ</productCode><productCodeName>Appliance, fixation, spinal intervertebral body</productCodeName></fdaProductCode><fdaProductCode><productCode>NKB</productCode><productCodeName>Thoracolumbosacral pedicle screw system</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>