{"publicDeviceRecordKey":"b8de7226-8a78-4595-a7f0-d251e62f9dc0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2025-10-24T00:00:00.000Z","devicePublishDate":"2015-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10889981043162","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Sierra™","versionModelNumber":"50-6150","catalogNumber":"50-6150","dunsNumber":"079840876","companyName":"Seaspine Orthopedics Corporation","deviceCount":1,"deviceDescription":"Rod, 3.5 x 50mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.","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(760)727-8399","phoneExtension":null,"email":"custsvcspine@seaspine.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K062934","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61235","gmdnPTName":"Cannulated surgical drill bit, single-use","gmdnPTDefinition":"A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KWP","productCodeName":"APPLIANCE, FIXATION, SPINAL INTERLAMINAL"},{"productCode":"MNI","productCodeName":"ORTHOSIS, SPINAL PEDICLE FIXATION"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"3.5 X 50mm"}]},"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}