{"publicDeviceRecordKey":"d0940dd1-352f-4221-9027-672f22555f1e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2026-01-08T00:00:00.000Z","devicePublishDate":"2018-01-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M711LS1950","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Excella MIS®","versionModelNumber":"LS-195","catalogNumber":"LS-195","dunsNumber":"141620464","companyName":"INNO Holdings, Inc.","deviceCount":1,"deviceDescription":"Silicone, SST\n","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"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":"801-261-2236","phoneExtension":null,"email":"info@innovasis.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44804","gmdnPTName":"Orthopaedic rod reducer","gmdnPTDefinition":"A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"32865","gmdnPTName":"Orthopaedic implant driver","gmdnPTDefinition":"A hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KWQ","productCodeName":"Appliance, Fixation, Spinal Intervertebral Body"},{"productCode":"KWP","productCodeName":"Appliance, Fixation, Spinal Interlaminal"},{"productCode":"MNH","productCodeName":"Orthosis, Spondylolisthesis Spinal Fixation"},{"productCode":"MNI","productCodeName":"Orthosis, Spinal Pedicle Fixation"},{"productCode":"NKB","productCodeName":"Thoracolumbosacral Pedicle Screw System"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}