{"publicDeviceRecordKey":"ee556210-f7c4-48d5-b133-2a1b8e0e55bb","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2023-02-20T00:00:00.000Z","devicePublishDate":"2016-08-24T00:00:00.000Z","deviceCommDistributionEndDate":"2026-12-31T00:00:00.000Z","deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M268102031081","deviceIdType":"Secondary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"10381780240297","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Cadence™","versionModelNumber":"10203108","catalogNumber":"10203108","dunsNumber":"942377524","companyName":"Ascension Orthopedics, Inc.","deviceCount":1,"deviceDescription":"Cadence Tibial Impactor Stop is uses to prevent excesssive impaction of the Tibial Tray.  The stop ensures that the implant is impacted only until the stop tabs contact the anterior tibia.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"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)654-2873","phoneExtension":null,"email":"custsvcnj@integralife.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"59009","gmdnPTName":"Orthopaedic implant/instrument assembling device","gmdnPTDefinition":"A non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LXH","productCodeName":"ORTHOPEDIC MANUAL SURGICAL INSTRUMENT"}]},"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":[]}}