{"publicDeviceRecordKey":"f84cd43c-ac4d-4387-914d-e1327f0ae8fb","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2026-05-29T00:00:00.000Z","devicePublishDate":"2015-09-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03596010479280","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ECHELON","versionModelNumber":"71342016","catalogNumber":"71342016","dunsNumber":"045483575","companyName":"Smith \u0026 Nephew, Inc.","deviceCount":1,"deviceDescription":"ECHELON 190MM POROUS PLUS HYDROXYAPATITE SIZE 16","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":[{"phone":"+1(800)238-7538","phoneExtension":null,"email":"GUDID@SMITH-NEPHEW.COM"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K090982","supplementNumber":"000"},{"submissionNumber":"K211176","supplementNumber":"000"},{"submissionNumber":"K963486","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33581","gmdnPTName":"Coated hip femur prosthesis, modular","gmdnPTDefinition":"A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined 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":"JDI","productCodeName":"Prosthesis, hip, semi-constrained, metal/polymer, cemented"},{"productCode":"LPH","productCodeName":"PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}