{"publicDeviceRecordKey":"68180c16-967e-4327-8c60-67dae39047f8","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-07-02T00:00:00.000Z","devicePublishDate":"2015-11-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00889095259124","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PROTEX","versionModelNumber":"109.372","catalogNumber":null,"dunsNumber":"139105691","companyName":"GLOBUS MEDICAL, INC.","deviceCount":1,"deviceDescription":"7.0mm PROTEX Monoaxial Screw, 6.0mm Rod, 30mm","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(610)930-1800","phoneExtension":null,"email":"info@globusmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K040442","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37272","gmdnPTName":"Trans-facet-screw internal spinal fixation system, sterile","gmdnPTDefinition":"A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"MNH","productCodeName":"Orthosis, spondylolisthesis spinal fixation"},{"productCode":"KWQ","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY"},{"productCode":"KWP","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERLAMINAL"},{"productCode":"NKB","productCodeName":"Orthosis, spinal pedicle fixation, for degenerative disc disease"},{"productCode":"MNI","productCodeName":"ORTHOSIS, SPINAL PEDICLE FIXATION"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"7"},"sizeText":null,"sizeString":"Outer Diameter: 7 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"30"},"sizeText":null,"sizeString":"Length: 30 Millimeter"}]},"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}