<?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>4c2cb60c-d955-4a1b-bdfa-6fd7be4cca9b</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2025-05-28</publicVersionDate><devicePublishDate>2020-01-06</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00887517021663</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>PRECICE® Plating System</brandName><versionModelNumber>LP4.5-MRT31</versionModelNumber><catalogNumber>LP4.5-MRT31</catalogNumber><dunsNumber>837845234</dunsNumber><companyName>NUVASIVE SPECIALIZED ORTHOPEDICS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 1-Hole
</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>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Unsafe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>866-456-2871</phone><phoneExtension xsi:nil="true"/><email>info@globusmedical.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K192181</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>64673</gmdnCode><gmdnPTName>Long bone distraction plate, magnetic</gmdnPTName><gmdnPTDefinition>An implantable device in the form of a plate, capable of adjusting in length, designed to be attached to a long bone to hold the ends of a fractured bone in position to promote healing, or to support the bone in the presence of a pathological condition, or for limb lengthening procedures; each plate is specific to a particular long bone (e.g., femur, humerus, tibia). It consists of overlapping plates, connected to the bone by locking screws, which have one or more integrated magnets that move in response to a noninvasive magnetic control device to adjust length.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HRS</productCode><productCodeName>Plate, Fixation, Bone</productCodeName></fdaProductCode><fdaProductCode><productCode>KTT</productCode><productCodeName>Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>