Total Hip replacement system - India CDSCO Medical Device Registration
Total Hip replacement system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000070_c0aa1ca53a245f19a42149602a09a398_b40d789c7f2f0446b00bf363b432d899. 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
The indications for use for total hip arthroplasty include: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. Stryker’s Exeter X3 RimFit Acetabular Cup is intended for cemented use only. Stryker THR All-Polyethylene Acetabular Cups are intended for cemented use only
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 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