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BIOCOMPOSITE SCREW - India CDSCO Medical Device Registration

BIOCOMPOSITE SCREW is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000152_8e8d52083247fd6cbccf0764feedf1ed_539c6d5d2ffaf5a2e521b5467c845f0b. This device is marketed under the brand name GenesysMatryx Interference Screw. 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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CDSCO Registered
Class Class D
BIOCOMPOSITE SCREW
UID: IMP/MD/2019/000152_8e8d52083247fd6cbccf0764feedf1ed_539c6d5d2ffaf5a2e521b5467c845f0b

Brand Name

GenesysMatryx Interference Screw

Device Class

Class D

Approving Authority

CDSCO

Product Information

GENESYS Matryx screws are intended for use in interference fixation of bone - patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions. GENESYS Matryx screws should be used in combination with appropriate immobilization/controlled mobilization. GENESYS Matryx screws are for attaching soft tissue to bone in orthopedic surgical procedures. GENESYS Matryx screws are intended to be used for interference fixation of soft tissue (GenesysMatryx Interference Screw) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone

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