{"publicDeviceRecordKey":"ade651a6-3eec-4ecb-886d-343ae16e8341","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-04-30T00:00:00.000Z","devicePublishDate":"2015-10-16T00:00:00.000Z","deviceCommDistributionEndDate":"2022-11-02T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00846832004362","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Ascend™","versionModelNumber":"502452","catalogNumber":"502452","dunsNumber":"968990812","companyName":"TORNIER, INC.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(888)494-7950","phoneExtension":null,"email":"customerservice@tornier.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"39702","gmdnPTName":"Coated shoulder humeral stem prosthesis","gmdnPTDefinition":"A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSD","productCodeName":"PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED"},{"productCode":"KWS","productCodeName":"PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED"},{"productCode":"KWT","productCodeName":"PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Thickness 20 mm"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"52"},"sizeText":null,"sizeString":"Outer Diameter: 52 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}