Calcium Phosohate Bone Substitute
- UID
- IMP/MD/2019/000418_df9dd5d397a3677c3df01827c5b7233f_be4a8c5c94bb7affe41d258967352eff
- Device class
- Class C
- Brand name
- Triosite
- Approving authority
- CDSCO
- Product information
- Triosite™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (Triosite) that are not intrinsic to the stability of the bony structure. Triosite™ 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. Triosite™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, Triosite™ gradually resorbs and is replaced with bone during the healing process. In addition, when used with appropriate opening osteotomy system devices, plates and screws, Triosite™ is intended to be used as bone void filler in femoral or tibial osteotomies. Triosite™ is to be used in association with adequate post-operative immobilization.
Calcium Phosohate Bone Substitute is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000418_df9dd5d397a3677c3df01827c5b7233f_be4a8c5c94bb7affe41d258967352eff. This device is marketed under the brand name Triosite. The license holder is Zimmer India Private Limited ,No. 17, Ground Floor and Mezzanine Floor, Thiruneermalai Road, Nagalkeni, Chrompet ,Chennai Tamil Nadu ,600044 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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