Calcium Phosohate Bone Substitute - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Calcium Phosohate Bone Substitute

UID: IMP/MD/2019/000418_df9dd5d397a3677c3df01827c5b7233f_be4a8c5c94bb7affe41d258967352eff

Brand Name

Triosite

License Holder

Zimmer India Private Limited ,No. 17, Ground Floor and Mezzanine Floor, Thiruneermalai Road, Nagalkeni, Chrompet ,Chennai Tamil Nadu ,600044 ,India

Device Class

Class C

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.

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Brand: Without Antibiotic

Class C