Bioabsorbable Implants - India CDSCO Medical Device Registration
Bioabsorbable Implants is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000127_9982ce16d32cf3565fe9a043f5656e0b_a2b0ad0fcd5ae269336c16eece4262cd. This device is marketed under the brand name Bioabsorbable Interference Screws. The license holder is M/s Linvatec India Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Bioabsorbable Interference Screws
License Holder
M/s Linvatec India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
BioScrew® Bioabsorbable Interference Screws: The BioScrew is used to provide interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone grafts and for femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft. Implantation of the interference screw is accomplished through arthroscopy or arthotomy. (Bioabsorbable Interference Screws) BioScrew® Bioabsorbable Femoral Interference Screws (Bioabsorbable Interference Screws): The BioScrew Femoral Interference Screw is used to provide femoral interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone grafts and for femoral fixation in anterior cruciate ligament reconstruction using a soft tissue graft. Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. (Bioabsorbable Interference Screws) BioScrew® XtraLok® Bioabsorbable Interference Screws: The BioScrewXtraLok Screw provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction. (Bioabsorbable Interference Screws)
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