Implant for High Tibial Osteotomy - India CDSCO Medical Device Registration
Implant for High Tibial Osteotomy is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000133_2bda7e332915f03ecff840ad0b44acc8_732dc014fbac25dec0d15cb76c617bc9. This device is marketed under the brand name BIO 1®. 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 D. The approving authority is CDSCO.
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Brand Name
BIO 1®
Device Class
Approving Authority
CDSCO
Product Information
OTIS®/OTIS 50® implants are used in Valgus Osteotomy of the Tibia using a medial metaphyseal incision. An osteosynthesis device such as OTIS-C® or OTIS-C-PLUS® must always be associated. OTIS® implants can be used with staple-type osteosynthesis devices. However, OTIS 50® implants, which offer lesser mechanical performances, must always be associated with a plate-and-screw osteosynthesis device such as OTIS-C® and OTIS-C Plus®
Resorbable Interference Screw
Brand: BIO 1®
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
Bone Substitute
Brand: BIO 1®
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