Rotating Hinge Knee System - Kinematic - India CDSCO Medical Device Registration
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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Brand Name
Antibiotic Simplex
License Holder
M/s Stryker India Private Ltd.,Device Class
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
Bone Cement(Simplex P Bone Cement )
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Antibiotic Bone Cement(Antibiotic Bone Cement Simplex P )
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Knee Replacement System-Patella
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Modular replacement System
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Modular replacement System
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Hip replacement system
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Knee Replacement System-Patellar components
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Knee replacement System
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Knee Replacement System - Triathlon All Poly Tibial Component
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Bone Cement
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
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AXS Vecta Intermediate Catheter
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AXS INFINITY LS PLUS Long Sheath
Brand: AXS INFINITY LS PLUS Long Sheath
SPS Instruments
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PRO System Instruments
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Trauma Plating System
Brand: Bone Screws
Bone Screws
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Trauma Plating System
Brand: PRO System
Defibrillator
Brand: LIFEPAK 20e Monitor/Defibrillator and accessories
Defibrillator
Brand: LIFEPAK 20e Monitor/Defibrillator and accessories