{"publicDeviceRecordKey":"56db9ba0-ca18-4d73-9573-87e21a7097b8","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-04-08T00:00:00.000Z","devicePublishDate":"2026-03-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04048844732011","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"implaFit®","versionModelNumber":"80092004","catalogNumber":null,"dunsNumber":"324369826","companyName":"implantcast GmbH","deviceCount":1,"deviceDescription":"short stem broach","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K252401","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35559","gmdnPTName":"Bone file/rasp, manual, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LZO","productCodeName":"Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented"},{"productCode":"MEH","productCodeName":"Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate"},{"productCode":"KWY","productCodeName":"Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"4"}]},"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}