{"publicDeviceRecordKey":"2a8d1a92-b656-4f08-8256-31274230c94c","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2024-10-18T00:00:00.000Z","devicePublishDate":"2016-09-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B030CP010080","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Orthros","versionModelNumber":"CP-010-08","catalogNumber":null,"dunsNumber":"054205979","companyName":"CAMBER SPINE TECHNOLOGIES, LLC","deviceCount":1,"deviceDescription":"Ø5.5mm CROSS LINK, 45mm-55mm\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-866-643-0739","phoneExtension":null,"email":"customerservice@cambermedtech.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K133366","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65114","gmdnPTName":"Bone-screw internal spinal fixation system connector","gmdnPTDefinition":"An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, 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)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KWQ","productCodeName":"Appliance, Fixation, Spinal Intervertebral Body"},{"productCode":"MNH","productCodeName":"Orthosis, Spondylolisthesis Spinal Fixation"},{"productCode":"MNI","productCodeName":"Orthosis, Spinal Pedicle Fixation"},{"productCode":"NKB","productCodeName":"Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease"}]},"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}