CDSCO UID MFG/MD/2019/000063_fd78ef0106070c1af6bd947a993c9caa_9d77ddb389f02c6324677ad9e31c0c92

SPINAL IMPLANTS

Zibon Surgitech·Device Class Class C·India CDSCO·Brand: INTRAMEDULLARY NAILS
Registration details
UID
MFG/MD/2019/000063_fd78ef0106070c1af6bd947a993c9caa_9d77ddb389f02c6324677ad9e31c0c92
Device class
Class C
Brand name
INTRAMEDULLARY NAILS
License holder
Zibon Surgitech
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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About this record

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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