{"publicDeviceRecordKey":"cd580977-acc1-433c-abb3-85aa31ab28d2","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-11-24T00:00:00.000Z","devicePublishDate":"2021-06-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08031497002118","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MectaCem-X LV","versionModelNumber":"65.01.103","catalogNumber":null,"dunsNumber":"435428396","companyName":"TECRES SPA","deviceCount":1,"deviceDescription":"MectaCem-X LV is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV is indicated for the fixation of joint prosthesis implants to the host bone.","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":"K021715","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35217","gmdnPTName":"Orthopaedic cement, non-antimicrobial","gmdnPTDefinition":"A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LOD","productCodeName":"Bone Cement"}]},"deviceSizes":{"deviceSize":[]},"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}