{"publicDeviceRecordKey":"620325a0-6871-4b80-8e0e-07f2566a9ea9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-12-10T00:00:00.000Z","devicePublishDate":"2018-05-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00841379123798","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"OLYMPIC","versionModelNumber":"AAQA80020","catalogNumber":"AAQA80020","dunsNumber":"073029645","companyName":"Astura Medical","deviceCount":1,"deviceDescription":"CORTICAL MONOAXIAL SCREW\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"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":"7608148047","phoneExtension":null,"email":"PARKER@ASTURAMEDICAL.COM"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46651","gmdnPTName":"Spinal bone screw, non-bioabsorbable","gmdnPTDefinition":"A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MNH","productCodeName":"Orthosis, Spondylolisthesis Spinal Fixation"},{"productCode":"MNI","productCodeName":"Orthosis, Spinal Pedicle Fixation"},{"productCode":"OSH","productCodeName":"Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"20"},"sizeText":null,"sizeString":"Length: 20 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"8.0"},"sizeText":null,"sizeString":"Outer Diameter: 8.0 Millimeter"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}