{"publicDeviceRecordKey":"88b3cf87-262c-473e-a080-19316282a27c","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-07-18T00:00:00.000Z","devicePublishDate":"2025-07-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00763000855505","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PYRAMESH® Implant System","versionModelNumber":"9050413","catalogNumber":null,"dunsNumber":"830350380","companyName":"MEDTRONIC SOFAMOR DANEK, INC.","deviceCount":1,"deviceDescription":"MESH 9050413  PYRM IMPL 10MMX14MMX13MM","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":"+1(800)633-8766","phoneExtension":null,"email":"Corporate.UDI@medtronic.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K183197","supplementNumber":"000"},{"submissionNumber":"K890601","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46580","gmdnPTName":"Extra-gynaecological surgical mesh, metal","gmdnPTDefinition":"A non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction); it is not primarily intended for dental use. Disposable devices associated with implantation may be supplied with the mesh.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EZX","productCodeName":"Mesh, surgical, metal"},{"productCode":"MQP","productCodeName":"Spinal vertebral body replacement device"}]},"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}