{"publicDeviceRecordKey":"9c040e7b-9f3e-4874-96d3-8e41ddc71e29","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-10-18T00:00:00.000Z","devicePublishDate":"2024-10-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00190837200060","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ProLift Wedge","versionModelNumber":"L180-104","catalogNumber":null,"dunsNumber":"183641617","companyName":"Life Spine, Inc.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K203361","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47814","gmdnPTName":"Orthopaedic implantation hammering attachment","gmdnPTDefinition":"A surgical instrument designed to be attached to another surgical implantation instrument or directly to an orthopaedic implant to provide a surface on which an operating surgeon can make strikes, with a surgical hammer or mallet, to insert an orthopaedic implant (e.g., an intramedullary nail). It is typically made of high-grade stainless steel and typically in the form of a cylindrical shaft with a threaded portion at the distal end (i.e., threaded into the implant or connected to the implantation instrument) and a broader, robust striking head (surface) at the proximal end. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MAX","productCodeName":"Intervertebral Fusion Device With Bone Graft, Lumbar"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}