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CDSCO UID IMP/MD/2020/000070_7b0bf5dc0a36bd704021b43dcea1812c_e41d7b20c65c313912f90c25274ecf7b

Bone Cement

M/s Stryker India Private Ltd.,·Device Class Class C·India CDSCO·Brand: Antibiotic Simplex
Registration details
UID
IMP/MD/2020/000070_7b0bf5dc0a36bd704021b43dcea1812c_e41d7b20c65c313912f90c25274ecf7b
Device class
Class C
Brand name
Antibiotic Simplex
License holder
M/s Stryker India Private Ltd.,
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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About this record

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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