{"publicDeviceRecordKey":"acf796a8-59d1-4521-b8be-5e2dcf9f58da","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-11-20T00:00:00.000Z","devicePublishDate":"2016-09-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"111106250","deviceIdType":"Direct Marking","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"M364111106FD2500","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Asfora Anterior Cervical Plate System","versionModelNumber":"11-1106-FD2-50","catalogNumber":null,"dunsNumber":"003815548","companyName":"MEDICAL DESIGNS  LLC","deviceCount":1,"deviceDescription":"2 Level, 50mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary\nstabilization to the anterior spine during the development of cervical spine\nfusions (C2-T1) for the following indications: degenerative disc disease (DDD)\n(defined as neck pain of discogenic origin with degeneration of the disc\nconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,\nfracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,\nkyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.","DMExempt":false,"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":"605-275-1032","phoneExtension":null,"email":"kspielman@medicaldesignsllc.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K143688","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46653","gmdnPTName":"Spinal fixation plate, non-bioabsorbable","gmdnPTDefinition":"A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KWQ","productCodeName":"Appliance, Fixation, Spinal Intervertebral Body"}]},"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}