{"publicDeviceRecordKey":"bcc54039-1d74-47f3-b822-ba15180eb0a3","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2026-10-16T00:00:00.000Z","devicePublishDate":"2015-10-30T00:00:00.000Z","deviceCommDistributionEndDate":"2021-01-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00813845020719","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SKaffold","versionModelNumber":"CMMX-FL10","catalogNumber":"CMMX-FL10","dunsNumber":"140071411","companyName":"SKELETAL KINETICS LLC","deviceCount":1,"deviceDescription":"SKaffold CMF Flow Bone Void Filler Mixing and Delivery System","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"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(408)366-5014","phoneExtension":null,"email":"cs@skeletalkinetics.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17751","gmdnPTName":"Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial","gmdnPTDefinition":"A bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GXP","productCodeName":"METHYL METHACRYLATE FOR CRANIOPLASTY"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Total Volume","size":{"unit":"Milliliter","value":"10"},"sizeText":null,"sizeString":"Total Volume: 10 Milliliter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"30"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"15"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}