{"publicDeviceRecordKey":"addea88e-9318-41db-8f4d-57c2f09084ec","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":9,"publicVersionDate":"2025-07-09T00:00:00.000Z","devicePublishDate":"2015-09-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00885556071908","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Peri-Loc","versionModelNumber":"73827080","catalogNumber":"73827080","dunsNumber":"045483575","companyName":"Smith \u0026 Nephew, Inc.","deviceCount":1,"deviceDescription":"PERI-LOC 4.5MM T25 LOCKING SCREW 80MM SELF-TAPPING","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":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)238-7538","phoneExtension":null,"email":"GUDID@SMITH-NEPHEW.COM"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K082516","supplementNumber":"000"},{"submissionNumber":"K210837","supplementNumber":"000"},{"submissionNumber":"K213126","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"66947","gmdnPTName":"Orthopaedic bone screw (non-sliding)","gmdnPTDefinition":"A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HWC","productCodeName":"Screw, fixation, bone"}]},"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}