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SPINAL IMPLANTS - India CDSCO Medical Device Registration

SPINAL IMPLANTS is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000063_fd78ef0106070c1af6bd947a993c9caa_9d77ddb389f02c6324677ad9e31c0c92. This device is marketed under the brand name INTRAMEDULLARY NAILS. The license holder is Zibon Surgitech, 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
UID: MFG/MD/2019/000063_fd78ef0106070c1af6bd947a993c9caa_9d77ddb389f02c6324677ad9e31c0c92

Brand Name

INTRAMEDULLARY NAILS

License Holder

Zibon Surgitech

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Spine System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (INTRAMEDULLARY NAILS), spondylolisthesis, trauma (INTRAMEDULLARY NAILS), spinal stenosis, spinal deformities (INTRAMEDULLARY NAILS), tumor, pseudarthrosis, or revision of a failed fusion attempt

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