{"publicDeviceRecordKey":"a35950d7-39bd-4a2e-804a-bd033cb20812","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2025-05-23T00:00:00.000Z","devicePublishDate":"2014-09-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00812301020249","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Biomet OrthoPak Non-invasive Bone Growth Stimulator System","versionModelNumber":"1067719","catalogNumber":"1067719","dunsNumber":"050410323","companyName":"EBI, LLC","deviceCount":1,"deviceDescription":"ORTHOPAK STIMULATOR, BIOMET\n","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":[{"phone":"1.973.299.9300","phoneExtension":null,"email":"btbs.csorders@biomet.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"P850022","supplementNumber":"017"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35463","gmdnPTName":"Patient-worn bone growth electromagnetic stimulator","gmdnPTDefinition":"A battery-powered, body-worn device designed to apply an electrical stimulus directly to bone to promote bone formation (i.e., osteogenesis). It is intended to generate an electromagnetic (EM) field (and its associated induced voltage effects) around a fracture or fusion site; it is not intended to apply an electric current directly to the body. The device is used as an alternative to bone grafting for non-union fractures (a condition in which the ends of a fractured bone fail to unite), and as a spinal fusion adjunct in treating degenerative vertebral diseases. It is also known as an osteogenesis stimulator.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LOF","productCodeName":"Stimulator, Bone Growth, Non-Invasive"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}