{"publicDeviceRecordKey":"40a057fa-7c97-4eba-8b73-87cbd61c9f05","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-03-19T00:00:00.000Z","devicePublishDate":"2023-08-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B565OS4230191","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Fuse ULTRA Foot plating System","versionModelNumber":"OS423019","catalogNumber":"OS423019","dunsNumber":"017138000","companyName":"CPM Medical Consultants, LLC","deviceCount":1,"deviceDescription":"Small Compressor Distractor Assembly\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"972-331-5860","phoneExtension":null,"email":"xx@xx.xx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K141784","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61802","gmdnPTName":"Bone tap, reprocessed","gmdnPTDefinition":"A sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end, and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached, whereby it will typically be manually rotated. This is a previously used single-use device that has been processed for an additional single-use patient application.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HWC","productCodeName":"Screw, 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}