{"publicDeviceRecordKey":"28627446-0124-4531-aef7-e8499aa32151","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":13,"publicVersionDate":"2026-03-31T00:00:00.000Z","devicePublishDate":"2017-06-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00817906021189","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CoLink™","versionModelNumber":"V35 ST420","catalogNumber":"V35 ST420","dunsNumber":"079700711","companyName":"In2Bones USA, LLC","deviceCount":1,"deviceDescription":"CoLink™ View Screw, Ø3.5 x 20mm,Transverse","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(866)426-6633","phoneExtension":null,"email":"CustomerExperience@conmed.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K163293","supplementNumber":"000"},{"submissionNumber":"K172300","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46647","gmdnPTName":"Orthopaedic fixation plate, non-bioabsorbable","gmdnPTDefinition":"A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. 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":"HRS","productCodeName":"Plate, Fixation, Bone"},{"productCode":"HWC","productCodeName":"Screw, Fixation, Bone"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Ø3.5 x20mm, Transverse"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}