<?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>486f46a6-aee0-4529-a20a-a3ed08f45ee6</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>6</publicVersionNumber><publicVersionDate>2026-01-23</publicVersionDate><devicePublishDate>2015-08-27</devicePublishDate><deviceCommDistributionEndDate>2023-12-23</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>E302BASC45309</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>ActivaScrew™</brandName><versionModelNumber>B-ASC-4530</versionModelNumber><catalogNumber>B-ASC-4530</catalogNumber><dunsNumber>368715301</dunsNumber><companyName>Bioretec Oy</companyName><deviceCount>1</deviceCount><deviceDescription>ActivaScrew™ Cannulated 4.5 x 30 mm</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 Safe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+358207789500</phone><phoneExtension xsi:nil="true"/><email>sales@bioretec.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K081392</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>45039</gmdnCode><gmdnPTName>Bioabsorbable orthopaedic bone screw</gmdnPTName><gmdnPTDefinition>A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A &quot;lag screw&quot; can be any of these used to obtain compression across bone fragments.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HWC</productCode><productCodeName>Screw, Fixation, Bone</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="4.5"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="30"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="86"/><storageHandlingLow unit="Degrees Fahrenheit" value="59"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="30"/><storageHandlingLow unit="Degrees Celsius" value="15"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>