{"publicDeviceRecordKey":"ff3bf183-7592-4f60-99a0-8e31f40ce2fa","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-08-27T00:00:00.000Z","devicePublishDate":"2017-01-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B06210101002","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Black Diamond Pedicle Screw System","versionModelNumber":"1010-1002","catalogNumber":"1010-1002","dunsNumber":"933442068","companyName":"Osseus Fusion Systems, LLC","deviceCount":1,"deviceDescription":"STRAIGHT SHARP PROBE, BLK DIAMOND\n","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":"888-330-5960","phoneExtension":null,"email":"Info@osseus.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"64192","gmdnPTName":"Internal spinal fixation procedure kit, reusable","gmdnPTDefinition":"A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MNI","productCodeName":"Orthosis, Spinal Pedicle Fixation"},{"productCode":"MNH","productCodeName":"Orthosis, Spondylolisthesis Spinal Fixation"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}