Synthetic bone void filler - India CDSCO Medical Device Registration
Synthetic bone void filler is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000108_a47f8d7c47222101005a6cad40bec954_5cb21530912e7b7d96134b4e260244d4. This device is marketed under the brand name ReBOSSIS / ReBOSSIS QDS. The license holder is CBC Corporation (India) Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
ReBOSSIS / ReBOSSIS QDS
License Holder
CBC Corporation (India) Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
ReBOSSIS / ReBOSSIS QDS is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ReBOSSIS / ReBOSSIS QDS is indicated to be packed gently into bony voids or gaps of the skeletal system (ReBOSSIS / ReBOSSIS QDS). In the extremities and pelvis ReBOSSIS / ReBOSSIS QDS may be used without hydration or hydrated with blood. In the posterolateral spine ReBOSSIS / ReBOSSIS QDS is to be used hydrated with bone marrow aspirate and mixed with autograft bone. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
