{"publicDeviceRecordKey":"34d6d801-458b-4950-bfe4-53c8d37c105e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2026-02-09T00:00:00.000Z","devicePublishDate":"2021-11-29T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B058ART13C151","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ART End Cap","versionModelNumber":"ART13C15","catalogNumber":"ART-13-C15","dunsNumber":"945518848","companyName":"Orthopedic Designs North America, Inc.","deviceCount":1,"deviceDescription":"ART End Cap Ø13mm x 15mm (+15)","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"888-635-8535","phoneExtension":null,"email":"support@odi-na.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K152295","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46139","gmdnPTName":"Bone nail implantable cap","gmdnPTDefinition":"A small, implantable, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. Commonly known as an end-cap, it is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HSB","productCodeName":"Rod, Fixation, Intramedullary And Accessories"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"13"},"sizeText":null,"sizeString":"Outer Diameter: 13 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"15"},"sizeText":null,"sizeString":"Length: 15 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"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}