{"publicDeviceRecordKey":"dddbeb70-3ea5-4fe7-a164-fdfa0569303b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-09-11T00:00:00.000Z","devicePublishDate":"2014-09-24T00:00:00.000Z","deviceCommDistributionEndDate":"2024-09-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M824SCPR65545CF1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"APEX Spine System","versionModelNumber":"SC-PR6-5545C-F","catalogNumber":null,"dunsNumber":"783908713","companyName":"SPINECRAFT, LLC","deviceCount":1,"deviceDescription":"Cannulated Polyaxial Reduction Screw, 5.50 x 45mm, Self-Tapping","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(630)920-7300","phoneExtension":null,"email":"info@spinecraft.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K110906","supplementNumber":"000"},{"submissionNumber":"K132603","supplementNumber":"000"}]},"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":"KWQ","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY"},{"productCode":"NKB","productCodeName":"Orthosis, spinal pedicle fixation, for degenerative disc disease"},{"productCode":"KWP","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERLAMINAL"},{"productCode":"MNI","productCodeName":"ORTHOSIS, SPINAL PEDICLE FIXATION"},{"productCode":"MNH","productCodeName":"Orthosis, spondylolisthesis spinal fixation"}]},"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}