{"publicDeviceRecordKey":"88c614a3-c486-4128-9cdf-41706714ee20","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-05-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033390017848","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"REVISION","versionModelNumber":"REVISION HIP - Ti6Al4V","catalogNumber":"7515.15.140","dunsNumber":"432066322","companyName":"LIMACORPORATE SPA","deviceCount":1,"deviceDescription":"Neck with Screw H=90mm Lateralized-Taper 12/14","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K151739","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34032","gmdnPTName":"Revision coated hip femur prosthesis","gmdnPTDefinition":"A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LZO","productCodeName":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented"},{"productCode":"LPH","productCodeName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented"},{"productCode":"KWY","productCodeName":"Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"H=90mm"}]},"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}