{"publicDeviceRecordKey":"85ff66f9-b10f-414f-be4c-86f62e9d74b3","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2025-11-20T00:00:00.000Z","devicePublishDate":"2015-10-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00880304491908","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DYNAFIX VS OSTEOTOMY SYSTEM","versionModelNumber":"10112P","catalogNumber":"10112P","dunsNumber":"129278169","companyName":"Biomet Orthopedics, LLC","deviceCount":1,"deviceDescription":null,"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":"+1(800)348-9500","phoneExtension":null,"email":"customerservice@zimmerbiomet.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K010551","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":"NDH","productCodeName":"NAIL, FIXATION, BONE, METALLIC"},{"productCode":"NDF","productCodeName":"PLATE, FIXATION, BONE, NON-SPINAL, METALLIC"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"11.25 MM 4 HOLE"}]},"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}