Plate and Screw Fixation System - India CDSCO Medical Device Registration
Plate and Screw Fixation System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000133_4859125549c436cd9f96a787b1be7809_81f57884ec67bd25707b3be82341f2ee. This device is marketed under the brand name OTIS-C/ OTIS-CPLUS/ OTIS-F. The license holder is EURO MEDI TOOLS PRIVATE LIMITED ,ONE HALL ON FIRST FLOOR PROPERTY NO A-54, FIEE COMPLEX, PHASE-2, OKHLA IND. AREA, NEW DELHI ,South Delhi Delhi ,110020 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
OTIS-C/ OTIS-CPLUS/ OTIS-F
Device Class
Approving Authority
CDSCO
Product Information
OTIS-C-PLUS® and OTIS-F® plates are intended for use in the temporary stabilization of long bone fractures. OTIS-C-PLUS® plates have been designed for Opening Wedge High Tibial Osteotomies (OTIS-C/ OTIS-CPLUS/ OTIS-F). OTIS-F® plates have been designed for distal femoral osteotomies and are suitable for opening as well as closing osteotomies, with a medial or lateral approach. The OTIS-F® plates and OTIS-C-PLUS® plates provide a complete solution for double level osteotomies around the knee. To be used with associated screws
