Spinal Implants PEEK
- UID
- MFG/MD/2023/000823_458da7741c4a98a8c3d5112adf9ec43d_9a2cb65b8c8e84c7fa3749dbb4b3ddd1
- Device class
- Class C
- Brand name
- Sterile
- License holder
- ELECTRO MAGNETIC INDUSTRIES
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Spinal Implants are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine; fracture, dislocation, failed previous fusion (Sterile), Spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors. Spinal implants are intended to be used a temporary construct that assists normal healing and are not intended to replace normal body structure. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after Fusion
Spinal Implants PEEK is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000823_458da7741c4a98a8c3d5112adf9ec43d_9a2cb65b8c8e84c7fa3749dbb4b3ddd1. This device is marketed under the brand name Sterile. The license holder is ELECTRO MAGNETIC INDUSTRIES, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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