Spinal Intervertebral Body Fixation Orthosis - India CDSCO Medical Device Registration

Spinal Intervertebral Body Fixation Orthosis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000329_a81da6ec3e559b36f0ec0077a1a5a7be_f4d21305c60b7a350d88166097af926c. This device is marketed under the brand name C7 Cage. The license holder is MEDYSSEY INDIA PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Spinal Intervertebral Body Fixation Orthosis

UID: IMP/MD/2021/000329_a81da6ec3e559b36f0ec0077a1a5a7be_f4d21305c60b7a350d88166097af926c

Brand Name

C7 Cage

License Holder

MEDYSSEY INDIA PRIVATE LIMITED

Device Class

Class D

Approving Authority

CDSCO

Product Information

Kora Spinal System are indicated for temporary or permanent correction or stabilization of the vertebral column and with the aim of helping consolidation of bone fusion. This Spinal System must be used with interbody fusion cage at the surgery for successful fusion They are indicated for: Primary surgery for advanced discopathies or extensive decompressions (C7 Cage) Spondylotic spinal stenosis Revision surgery for failed disc operation Post-operative instability Disc herniation Spondylosis with bone spurring, foraminal narrowing and nerve root impingement Chronic and disabling discogenic low back pain Spinal pseudarthrosis.