Modular replacement System - India CDSCO Medical Device Registration
Modular replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000070_c3b6183ab2bcf7177ca21f6d5c971e76_e9a692fbf147fa1b7013ea29d97500a6. 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
It is intended for use in oncology patients requiring extensive reconstruction of the proximal tibia and/or proximal humerous including the Knee joint anf knee fusions, necessitated by extensive bone loss due to tumor resection .These prosthesis are intended for use with bone cement as a means of intramedullary fixation
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.,
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.,
Rotating Hinge Knee System - Kinematic
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Bone Cement
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Inzone Detachment System
Brand: Inzone Detachment System
AXS Vecta Intermediate Catheter
Brand: AXS INFINITY LS PLUS Long Sheath
AXS INFINITY LS PLUS Long Sheath
Brand: AXS INFINITY LS PLUS Long Sheath
SPS Instruments
Brand: SPS
PRO System Instruments
Brand: SPS
Trauma Plating System
Brand: Bone Screws
Bone Screws
Brand: Bone Screws
Trauma Plating System
Brand: PRO System
Defibrillator
Brand: LIFEPAK 20e Monitor/Defibrillator and accessories
Defibrillator
Brand: LIFEPAK 20e Monitor/Defibrillator and accessories