Bone Cement - India CDSCO Medical Device Registration
Bone Cement is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000070_7b0bf5dc0a36bd704021b43dcea1812c_e41d7b20c65c313912f90c25274ecf7b. 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
Simplex™ P SpeedSet™ Bone Cement (Antibiotic Simplex) is indicated for the fixation of prostheses to living bone in orthopaedicmusculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, sickle cell anemia, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty procedures. The cement is also indicated for the fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective
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