Instrument system for Total elbow Replacement system - India CDSCO Medical Device Registration
Instrument system for Total elbow Replacement system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000266_791bb60ed333081a19a81105e30821f7_f68b25fe5aa6f1e0db3d28920d2a78a6. The license holder is RCH ORTHOPAEDICS, and it is classified as Device Class Class B. The approving authority is Kokan Division.
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License Holder
RCH ORTHOPAEDICSDevice Class
Approving Authority
Kokan Division
Product Information
The instrument system for Total Elbow Replacement System is used in surgical procedure for Total Elbow Replacement In total elbow replacement surgery, the damaged parts of the humerus and ulna are replaced with artificial components. The artificial elbow joint is made up of a metal and plastic hinge with two metal stems. The stems fit inside the hollow part of the bone called the canal. The instrument system for Total Elbow replacement System used in surgical procedure includes โsynovial joint exposure with retractor /lever with or without cement preparation humeral component and ulnar preparation with or without cement usage. Surgical instrumentation used in surgical procedure starts with humeral joint exposure by cutting guide and guide rod ,rasping of the humeral cavity and decision of cemented or cementless humerus component followed by Ulnar cavity preparation with ulnar drill reamer and ulnar rasp. Trials for temporary sizing guide to check the size and fit of orthopaedic implants before actual implantation of the device. Trials or provisionals of the humeral and ulnar components always assembled with collet pin to form a hinge for checking the range of motion

