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CDSCO UID IMP/MD/2020/000070_89629b029d5a680ed2edaf9588c15625_fead61be57fc6b709d30cae97f6a79a8

Rotating Hinge Knee System - Kinematic

M/s Stryker India Private Ltd.,·Device Class Class C·India CDSCO·Brand: Antibiotic Simplex
Registration details
UID
IMP/MD/2020/000070_89629b029d5a680ed2edaf9588c15625_fead61be57fc6b709d30cae97f6a79a8
Device class
Class C
Brand name
Antibiotic Simplex
License holder
M/s Stryker India Private Ltd.,
Approving authority
CDSCO
Product information
Hinge Knee Systems are intended to be implanted with bone cement for the following condition(Antibiotic Simplex): 1. There is destruction of the joint surfaces, with or without significant bone deformity. The cruciate and/or collateral ligaments do not stabilize the knee joint. The ligaments are inadequate and/or the musculature is weak. And/or, Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue
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About this record

Rotating Hinge Knee System - Kinematic is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000070_89629b029d5a680ed2edaf9588c15625_fead61be57fc6b709d30cae97f6a79a8. This device is marketed under the brand name Antibiotic Simplex. The license holder is M/s Stryker India Private Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.

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