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Hip/Knee Replacement System-Segmental Component(Limb Preservation System ) - India CDSCO Medical Device Registration

Hip/Knee Replacement System-Segmental Component(Limb Preservation System ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000029_ecdf2296f596dfddfa432046a5a63e6f_fd673bd7a35a2bfeeb04fb33c5661ee0. This device is marketed under the brand name LPS. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Hip/Knee Replacement System-Segmental Component(Limb Preservation System )
UID: IMP/MD/2019/000029_ecdf2296f596dfddfa432046a5a63e6f_fd673bd7a35a2bfeeb04fb33c5661ee0

Brand Name

LPS

Device Class

Class D

Approving Authority

CDSCO

Product Information

The LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: 1. malignant tumors (LPS) requiring extensive resection and replacement; 2. patient conditions of noninflammatory degenerative joint disease (LPS), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (LPS), e.g., rheumatoid arthritis, requiring extensive resection and replacement; 3. revision cases for a failed previous prosthesis requiring extensive resection and replacement; 4. severe trauma requiring extensive resection and replacement. The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required

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