Synthetic Bone substitute - India CDSCO Medical Device Registration
Synthetic Bone substitute is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000309_b95ba117fff72df48cd20f0715d5431a_e337ebcd9d6faa905636084b5834f14c. This device is marketed under the brand name MBCP, B-Wedge. The license holder is Chetan Meditech Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
MBCP, B-Wedge
License Holder
Chetan Meditech Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The Synthetic Bone Substitute is intended for use as a bone void filler for bony voids or gaps of the skeletal system (MBCP, B-Wedge) that are not intrinsic to the stability of the bony structure. The Synthetic Bone Substitute can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Synthetic Bone Substitute is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, The Synthetic Bone Substitute gradually resorbs and is replaced with bone during the healing process. In addition, when used with appropriate opening osteotomy system devices, plates and screws. The Synthetic Bone substitute is intended to be used as a bone void filler in femoral or tibial osteotomies. The Synthetic Bone Substitute is to be used in association with adequate post-operative immobilization
