CDSCO UID IMP/MD/2022/000044_d94acf38912c91648fd59504e925107e_83410ac11e674a07d08ddaa5f51a8095
Concorde Spine System Spinal System - Non-Sterile - Polymer Carbon fiber Composite
Johnson & Johnson Private Limited·Device Class Class C·India CDSCO·Brand: Non-Sterile
Registration details
- UID
- IMP/MD/2022/000044_d94acf38912c91648fd59504e925107e_83410ac11e674a07d08ddaa5f51a8095
- Device class
- Class C
- Brand name
- Non-Sterile
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- Product information
- The CONCORDE, CONCORDE Bullet, CONCORDE Inline, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (Non-Sterile) at one or two contiguous levels of the lumbar spine (Non-Sterile). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (Non-Sterile), TLIF (Non-Sterile) or anterior (Non-Sterile) This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (Non-Sterile). The onus resides with the user to ensure that the most up-to-date IFU is used. 2 of 8 approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products. The CONCORDE, CONCORDE Bullet, CONCORDE Inline, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (Non-Sterile) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products
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About this record
Concorde Spine System Spinal System - Non-Sterile - Polymer Carbon fiber Composite is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000044_d94acf38912c91648fd59504e925107e_83410ac11e674a07d08ddaa5f51a8095. 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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