36bb27a5-51cb-4481-9b5f-99d6f6f9fb4dUpdatePublished42018-11-122015-09-242018-11-11Not in Commercial Distribution04573190050125PrimaryGS1ReBOSSIS1.0gORB-0110B691435666ORTHOREBIRTH CO.,LTD.1ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide). The electrospinning process used in manufacturing ReBOSSIS results in a cotton-like physical form. Due to its physical form, ReBOSSIS is flexible and can easily fill defects in appropriate amounts.falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse866-426-2323dblake@orthorebirthusa.comK14209000016966Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.trueActiveMQVFiller, Bone Void, Calcium CompoundTotal VolumeStorage Environment TemperatureSpecial Storage Condition, SpecifyStore in a dry placetruefalse