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CONFIDENCE Kit Spinal Cement System Cement Kit ) -Sterile - PMMA - India CDSCO Medical Device Registration

CONFIDENCE Kit Spinal Cement System Cement Kit ) -Sterile - PMMA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000044_8475ee28a226964d73f17b8c9d81f3ba_a8eeef25a0c2ca86aff59a8da14f4916. This device is marketed under the brand name Non-Sterile. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
CONFIDENCE Kit Spinal Cement System Cement Kit ) -Sterile - PMMA
UID: IMP/MD/2022/000044_8475ee28a226964d73f17b8c9d81f3ba_a8eeef25a0c2ca86aff59a8da14f4916

Brand Name

Non-Sterile

Device Class

Class C

Approving Authority

CDSCO

Product Information

The CONFIDENCE SPINAL CEMENT SYSTEM โ€“11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (Non-Sterile), and malignant lesions (Non-Sterile). The CONFIDENCE High Viscosity Spinal Cement may also be used in conjuction with the VIPER and EXPEDIUM Fenestrated Screw Systems, including VERSE

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