{"publicDeviceRecordKey":"3f2184c1-f869-417b-91d8-f61edab35e05","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-07-02T00:00:00.000Z","devicePublishDate":"2015-07-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M719GL32110","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TiLock","versionModelNumber":"1","catalogNumber":"GL321-1","dunsNumber":"017921066","companyName":"Genesys Orthopedics Systems LLC","deviceCount":1,"deviceDescription":"Pedicle Marker - Smooth","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":"512-381-7070","phoneExtension":null,"email":"info@genesysspine.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K100757","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61325","gmdnPTName":"Bone-screw internal spinal fixation system, non-sterile","gmdnPTDefinition":"An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"NKB","productCodeName":"Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease"},{"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}