BONE SCREWS - India CDSCO Medical Device Registration

BONE SCREWS is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000196_fa899770a1daec6671c2507cb8a5165a_d49f1c5daed624df38b461271ae87971. 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

BONE SCREWS

UID: MFG/MD/2019/000196_fa899770a1daec6671c2507cb8a5165a_d49f1c5daed624df38b461271ae87971

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

SCREWS (SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES) ALONG WITH PLATES, NAILS, PINS AND WIRES ARE INDICATED FOR PELVIC, SMALL AND LONG BONE FRACTURE FIXATION. SCREWS ARE USED EITHER TO FASTEN PLATES, INTERLOCKING NAILS OR SIMILAR DEVICES ONTO BONES, OR, AS LAG SCREWS, TO HOLD BONE FRAGMENTS TOGETHER AFFECTED BY TRAUMA OR FOR RECONSTRUCTION OR ARTHRODESIS. SCREW IS INDICATED FOR USE IN BONE RECONSTRUCTION, OSTEOTOMY, ARTHRODESIS, JOINT FUSION, FRACTURE REPAIR, AND FRACTURE FIXATION, APPROPRIATE FOR THE SIZE OF THE DEVICE. WASHERS MAY BE USED WITH THE SCREWS IN CERTAIN APPLICATIONS