<?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>53ecaa42-29be-4a1d-b13d-b71b583e3b1e</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2026-05-06</publicVersionDate><devicePublishDate>2026-04-28</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08809885702007</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>PYXIS 3D Titanium Cage System</brandName><versionModelNumber>8022-0011S</versionModelNumber><catalogNumber>8022-0011S</catalogNumber><dunsNumber>688385418</dunsNumber><companyName>GS Medical Co., Ltd.</companyName><deviceCount>1</deviceCount><deviceDescription>The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral space after resection of the disc.The PYXIS 3D Titanium Cage  devices consist of implants in various heights, footprints, and lordotic configurations with architecture designed to accept pre and post packing of bone graft material. The intervertebral body devices are made of titanium alloy (Ti-6AL-4V ELI).The PYXIS 3D Titanium Cage  devices are not radio lucent, but have large windows through the sides that will allow visualization of the placement and subsequent bone fusion. </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>false</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><customerContact><phone>+82432377393</phone><phoneExtension xsi:nil="true"/><email>udimail@gsmedi.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K223868</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>38161</gmdnCode><gmdnPTName>Metallic spinal interbody fusion cage</gmdnPTName><gmdnPTDefinition>A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MAX</productCode><productCodeName>Intervertebral Fusion Device With Bone Graft, Lumbar</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>