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/2019/000196_fd78ef0106070c1af6bd947a993c9caa_b9325bc6fe9aeebbd79fe39b82bee08f. This device is marketed under the brand name SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES. The license holder is DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED, 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/2019/000196_fd78ef0106070c1af6bd947a993c9caa_b9325bc6fe9aeebbd79fe39b82bee08f

Brand Name

SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES

License Holder

DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED

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 THE FOLLOWING ACUTE AND CHRONIC INSTABILITIES OR DEFORMITIES OF THORACIC, LUMBAR, AND SACRAL SPINE: FRACTURE, DISLOCATION, FAILED PREVIOUS FUSION (SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES), 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 AS A TEMPORARY CONSTRUCT THAT ASSISTS NORMAL HEALING AND ARE NOT INTENDED TO REPLACE NORMAL BODY STRUCTURES. THEY ARE INTENDED TO STABILIZE THE SPINAL OPERATIVE SITE DURING FUSION PROCEDURES AND SHOULD BE REMOVED AFTER FUSION