{"publicDeviceRecordKey":"e17fa70f-4428-440e-ab3f-9c20b80f87e9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2024-09-11T00:00:00.000Z","devicePublishDate":"2014-12-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04546540468987","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"XIA II","versionModelNumber":"03820136","catalogNumber":"03820136","dunsNumber":"149183167","companyName":"Stryker Corporation","deviceCount":1,"deviceDescription":"LARGE ROD-ROD CONNECTOR","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65114","gmdnPTName":"Bone-screw internal spinal fixation system connector","gmdnPTDefinition":"An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MNI","productCodeName":"ORTHOSIS, SPINAL PEDICLE FIXATION"},{"productCode":"KWP","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERLAMINAL"},{"productCode":"MNH","productCodeName":"Orthosis, spondylolisthesis spinal fixation"},{"productCode":"NKB","productCodeName":"Orthosis, spinal pedicle fixation, for degenerative disc disease"},{"productCode":"KWQ","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Degree: 0.0 Degree"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}