{"publicDeviceRecordKey":"3a811041-1fcb-4cbe-9d2b-055650589059","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2024-11-11T00:00:00.000Z","devicePublishDate":"2017-02-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"90814008023847","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"tangis","versionModelNumber":"ACP-425-20V","catalogNumber":null,"dunsNumber":"047486041","companyName":"NVISION BIOMEDICAL TECHNOLOGIES, INC.","deviceCount":1,"deviceDescription":"Anterior Cervical Plating System, 4.25mm dia. 20mm long variable screw.  The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It\nis to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:  • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis","DMExempt":true,"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":"210-545-3713","phoneExtension":null,"email":"diana@nvisionbiomed.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K161524","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"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Height","size":{"unit":"Millimeter","value":"20"},"sizeText":null,"sizeString":"Height: 20 Millimeter"},{"sizeType":"Width","size":{"unit":"Millimeter","value":"4.25"},"sizeText":null,"sizeString":"Width: 4.25 Millimeter"},{"sizeType":"Depth","size":{"unit":"Millimeter","value":"4.25"},"sizeText":null,"sizeString":"Depth: 4.25 Millimeter"}]},"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}