<?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>fe1b723e-2aac-4e49-b95d-e1fadc855dcc</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>7</publicVersionNumber><publicVersionDate>2025-07-02</publicVersionDate><devicePublishDate>2015-10-23</devicePublishDate><deviceCommDistributionEndDate>2021-10-04</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>03613720184829</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>PASS LP</brandName><versionModelNumber>B02314560</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>383228632</dunsNumber><companyName>MEDICREA INTERNATIONAL</companyName><deviceCount>1</deviceCount><deviceDescription>SHORT POST DUAL LEAD PEDICLE SCREW Ø 4.5mm x 60mm
</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>true</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/><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>NKB</productCode><productCodeName>Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>