{"publicDeviceRecordKey":"e2806168-3dc0-41cc-92c2-b86dcb3fcee2","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-03-13T00:00:00.000Z","devicePublishDate":"2018-09-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840996174572","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"HARRIER-SA Lumbar Interbody System","versionModelNumber":"Y070-0037","catalogNumber":null,"dunsNumber":"078293017","companyName":"Choice Spine, LP","deviceCount":1,"deviceDescription":"HARRIER-SA,GRAFT BLOCK","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":[{"phone":"+1(865)246-3333","phoneExtension":null,"email":"info@choicespine.net"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K180519","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47743","gmdnPTName":"Bone graft packing block","gmdnPTDefinition":"A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MAX","productCodeName":"Intervertebral fusion device with bone graft, lumbar"},{"productCode":"OVD","productCodeName":"Intervertebral fusion device with integrated fixation, 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}