<?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>4d815494-4ae4-435a-abb9-9e23a0abaeaa</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>8</publicVersionNumber><publicVersionDate>2026-01-01</publicVersionDate><devicePublishDate>2017-02-07</devicePublishDate><deviceCommDistributionEndDate>2026-01-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M224PLT10309</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>1.5 mm Inion CPS®</brandName><versionModelNumber>1</versionModelNumber><catalogNumber>PLT-1030</catalogNumber><dunsNumber>367994657</dunsNumber><companyName>Inion Oy</companyName><deviceCount>1</deviceCount><deviceDescription>Mesh plate, 7x7 holes</deviceDescription><DMExempt>true</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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><premarketSubmissions><premarketSubmission><submissionNumber>K010352</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>44688</gmdnCode><gmdnPTName>Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable</gmdnPTName><gmdnPTDefinition>An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polyglycolide] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JEY</productCode><productCodeName>PLATE, BONE</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>