{"publicDeviceRecordKey":"ae5faf44-9224-4441-b07a-9c251c53a3e0","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-05-10T00:00:00.000Z","devicePublishDate":"2021-04-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M5726556C012011","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Triathlon AS-1 PS Box Ream Cementless Instrumentation Kit ","versionModelNumber":"6556C01201","catalogNumber":"6556-C-012","dunsNumber":"808821883","companyName":"Conformis, Inc.","deviceCount":1,"deviceDescription":"Triathlon AS-1  PS Surgical Instruments, Cementless, PS insert, box ream, sizes 0-8, Right and Left","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":false,"serialNumber":true,"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":"781-345-9001","phoneExtension":null,"email":"customer-service@conformis.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K203421","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58910","gmdnPTName":"Total knee prosthesis implantation guide-instrument kit","gmdnPTDefinition":"A collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Components may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components; the implant is not included. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OOG","productCodeName":"Knee Arthroplasty Implantation System"},{"productCode":"JWH","productCodeName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Femur prep size 0 to size 8; tibial prep size 0 to size 8"}]},"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}