CDSCO UID MFG/MD/2023/000266_791bb60ed333081a19a81105e30821f7_f68b25fe5aa6f1e0db3d28920d2a78a6
Instrument system for Total elbow Replacement system
RCH ORTHOPAEDICS·Device Class Class B·India CDSCO
Registration details
- UID
- MFG/MD/2023/000266_791bb60ed333081a19a81105e30821f7_f68b25fe5aa6f1e0db3d28920d2a78a6
- Device class
- Class B
- License holder
- RCH ORTHOPAEDICS
- 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 –synovial 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
Other products from RCH ORTHOPAEDICS
Products from the same license holder (10 products)
Instrument System for Limb Salvage System
Class B
Rasp
Class B
Instrument System for Total Hip System
Class B
Instrument System for Total Knee System
Class B
Instrument system for Total Shoulder Replacement system
Class B
Trial
Class B
DRILL
Class A
Scraping, Cutting and Dissecting Surgical instruments
Class A
Instrument system for Shoulder Replacement system
Class A
Impactor
Class A
About this record
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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.