Lumber Spacer - India CDSCO Medical Device Registration

Lumber Spacer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000005_d58404d6a47c25f5b4bb1b0e441123ca_76ee0745f44f1b5786d9679ebf359022. This device is marketed under the brand name TRANSITION Stabilization System. The license holder is M/s Globus Medical India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Lumber Spacer

UID: IMP/MD/2019/000005_d58404d6a47c25f5b4bb1b0e441123ca_76ee0745f44f1b5786d9679ebf359022

Brand Name

TRANSITION Stabilization System

License Holder

M/s Globus Medical India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Intended for the cervical spine (TRANSITION Stabilization System), for anterior cervical discectomy and fusion (TRANSITION Stabilization System) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These devices are recommended to be used with supplemental spinal fixation systems for cervical spine (TRANSITION Stabilization System)

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Cervical Plate System -: intended for anterior screw fixation to the cervical spine C2

Brand: TRANSITION Stabilization System

M/s Globus Medical India Pvt. Ltd.

Lumber Spacer - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Cervical Plate System -: intended for anterior screw fixation to the cervical spine C2

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Cervical Plate System -: intended for anterior screw fixation to the cervical spine C2

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