{"publicDeviceRecordKey":"393388c0-8b2b-46d6-a5f0-a92b344f8c6d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-07-02T00:00:00.000Z","devicePublishDate":"2015-10-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033726408944","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PLS","versionModelNumber":" PLS-49T51","catalogNumber":null,"dunsNumber":"544150399","companyName":"SINTEA PLUSTEK SRL","deviceCount":1,"deviceDescription":null,"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":"MR Unsafe","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K060513","supplementNumber":"000"},{"submissionNumber":"K081631","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":"KWP","productCodeName":"Appliance, Fixation, Spinal Interlaminal"}]},"deviceSizes":{"deviceSize":[]},"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}