{"publicDeviceRecordKey":"e1d91e60-d676-4c27-a04a-124c0f5a21b7","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-05-30T00:00:00.000Z","devicePublishDate":"2018-07-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00841036253233","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PECTUS SYSTEM","versionModelNumber":"PT-2645","catalogNumber":null,"dunsNumber":"046189866","companyName":"BIOMET MICROFIXATION, INC","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":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"904-741-4400","phoneExtension":null,"email":"FXJAX-ORDERS@BIOMET.COM"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K061384","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61522","gmdnPTName":"Funnel chest remodelling bar","gmdnPTDefinition":"A non-sterile implantable device intended to be used to reduce the deformity of pectus excavatum (funnel chest) by applying outward force from a position deep to the sternum to reposition the sternum; it is typically used in paediatric patients and surgically removed when remodelling is evident (after 2-3 years). It is a thin curved bar, with or without serrations, made of metal [e.g., stainless steel, titanium (Ti)] that can be anchored with wires or with stabilizer plates laterally on the rib cage. This is a single-patient device intended to be sterilized prior to use.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HRS","productCodeName":"Plate, Fixation, Bone"}]},"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}