Spinal Implants PEEK - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Spinal Implants PEEK

UID: MFG/MD/2023/000823_458da7741c4a98a8c3d5112adf9ec43d_9a2cb65b8c8e84c7fa3749dbb4b3ddd1

Brand Name

Sterile

License Holder

ELECTRO MAGNETIC INDUSTRIES

Device Class

Class C

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

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Prosthesis, Total Knee Replacement {SS}

Brand: Sterile

ELECTRO MAGNETIC INDUSTRIES

Spinal Implants PEEK - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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