{"publicDeviceRecordKey":"c2d9c702-f95d-416b-acfa-fe3ea0342288","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-05-16T00:00:00.000Z","devicePublishDate":"2018-12-15T00:00:00.000Z","deviceCommDistributionEndDate":"2025-05-15T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00814008029662","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"FOCUS","versionModelNumber":"M-01-065","catalogNumber":null,"dunsNumber":"047486041","companyName":"NVISION BIOMEDICAL TECHNOLOGIES, INC.","deviceCount":1,"deviceDescription":"Rod, MIS, Lordotic 5.5X65mm.  The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.","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":"K180458","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65116","gmdnPTName":"Bone-screw internal spinal fixation system rod","gmdnPTDefinition":"An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder 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 designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NKB","productCodeName":"Thoracolumbosacral Pedicle Screw System"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"65"},"sizeText":null,"sizeString":"Length: 65 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"5.5"},"sizeText":null,"sizeString":"Outer Diameter: 5.5 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime."}]},"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}