{"publicDeviceRecordKey":"8f596911-d2be-4dcf-bbe3-95068eedb071","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-05-30T00:00:00.000Z","devicePublishDate":"2019-04-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00887868308024","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"RingLoc® Mallory-Head® Hip System","versionModelNumber":"13-104144","catalogNumber":"13-104144","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":true,"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":"K030055","supplementNumber":"000"},{"submissionNumber":"K921181","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33175","gmdnPTName":"Metallic femoral head prosthesis","gmdnPTDefinition":"An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MEH","productCodeName":"Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate"},{"productCode":"LPH","productCodeName":"PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED"},{"productCode":"LZO","productCodeName":"Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"44 mm 21 Liner Size"}]},"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}