Resorbable Interference Screw - India CDSCO Medical Device Registration
Resorbable Interference Screw is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000133_e0500eba84d0d30541925dbd87e7b63a_d5ffec536780975eccb7a6f1e708584e. 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
The LIGAFIX® 30 Interference Screw is designed for interference fixation in anterior cruciate ligament reconstruction. The LIGAFIX® 60 Interference Screw is exclusively used for interference fixation of a soft tissue transplant, for instance from the hamstring tendon, when reconstructing the anterior cruciate ligament. The screws are cannulated and are available in different sizes (BIO 1®). They have a specific head, which allows for a more even distribution of the torsional stresses. To achieve an optimal result, the LIGAFIX® Interference Screws should be implanted using the dedicated screwdriver contained in the instrumentation set. - Flat head screws are recommended to reduce the stresses on the screw. Using LIGAFIX® screws is appropriate when implanting 10-11mm diameter screws and in the KJ technique (BIO 1®) for LIGAFIX® 30. - Round head screws are recommended to limit friction on the graft, specifically for femoral fixation and soft tissue grafts for LIGAFIX® 60.
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
Implant for High Tibial Osteotomy
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
Resorbable Interference Screw
Brand: ComposiTCP 60 Interference Screw
Zimmer India Private Limited ,No. 17, Ground Floor and Mezzanine Floor, Thiruneermalai Road, Nagalkeni, Chrompet ,Chennai Tamil Nadu ,600044 ,India
Resorbable Interference Screw
Brand: ComposiTCP 60 Interference Screw
Zimmer India Private Limited ,No. 17, Ground Floor and Mezzanine Floor, Thiruneermalai Road, Nagalkeni, Chrompet ,Chennai Tamil Nadu ,600044 ,India