{"publicDeviceRecordKey":"496bdfd1-b899-4cf1-812d-b3e8731dcadf","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2024-09-05T00:00:00.000Z","devicePublishDate":"2014-09-24T00:00:00.000Z","deviceCommDistributionEndDate":"2024-09-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M824SCOL650951","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"APEX Spine System","versionModelNumber":"SC-OL6-5095","catalogNumber":null,"dunsNumber":"783908713","companyName":"SPINECRAFT, LLC","deviceCount":1,"deviceDescription":"Offset Left Hook 9.5mm","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":"K062513","supplementNumber":"000"},{"submissionNumber":"K092825","supplementNumber":"000"},{"submissionNumber":"K102488","supplementNumber":"000"},{"submissionNumber":"K110906","supplementNumber":"000"},{"submissionNumber":"K132603","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65115","gmdnPTName":"Bone-screw internal spinal fixation system hook","gmdnPTDefinition":"An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KWQ","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY"},{"productCode":"MNH","productCodeName":"Orthosis, spondylolisthesis spinal fixation"},{"productCode":"KWP","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERLAMINAL"},{"productCode":"NKB","productCodeName":"Orthosis, spinal pedicle fixation, for degenerative disc disease"},{"productCode":"MNI","productCodeName":"ORTHOSIS, SPINAL PEDICLE 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}