{"publicDeviceRecordKey":"214d3324-5650-4b19-aac9-83ba99ea5dd0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2022-06-10T00:00:00.000Z","devicePublishDate":"2015-10-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840420121813","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ORTHOSPHERE","versionModelNumber":"8530014","catalogNumber":"8530014","dunsNumber":"807201207","companyName":"WRIGHT MEDICAL TECHNOLOGY, INC.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)238-7117","phoneExtension":null,"email":"customerservice@wmt.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35663","gmdnPTName":"Total wrist carpal articulation prosthesis","gmdnPTDefinition":"An implantable device designed to replace some of the carpal bone articulating surfaces as part of a total wrist replacement, typically to treat severe bone fracture or degenerative disease (e.g., arthritis). It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is implanted into hand bone distally; it may interface with a spacer. Fixation devices for implantation (e.g., screws) may be included with the prosthesis and implantation may be performed with or without bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KWD","productCodeName":"PROSTHESIS, TOE, HEMI-, PHALANGEAL"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"14"},"sizeText":null,"sizeString":"Outer Diameter: 14 Millimeter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Size: 14mm"}]},"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":[]}}