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DRILL - India CDSCO Medical Device Registration

DRILL is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000678_fde670dc95a07e861e0cfe7b0e877253_606a73a5545681e0c7d448b66fd85094. The license holder is RCH ORTHOPAEDICS, and it is classified as Device Class Class A. The approving authority is Kokan Division.

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CDSCO Registered
Class Class A
DRILL
UID: MFG/MD/2022/000678_fde670dc95a07e861e0cfe7b0e877253_606a73a5545681e0c7d448b66fd85094

License Holder

RCH ORTHOPAEDICS

Device Class

Class A

Approving Authority

Kokan Division

Product Information

'Bone drilling' is a universal surgical method generally employed in internal fracture fixation, install implants, or to carryout reconstructive surgery. The main purpose of bone drilling is to produce holes for fixing screws, wires and plates to fasten the fractured parts for immobilisation. Bone fracture treatment involves bone drilling to fix fractured bone with specialised equipment. Bone is an organic, mineralised, and hard type of tissue. The drilling process is influenced by drill, shape, drill bit material, and bone structure1. In drilling operations, a thrust force is induced in the direction opposite to the drilling direction in relation to the cutting force of the drill bit. The cutting force is dependent on drill bit geometry, drill speed, and drill torque2, 3. Thrust force can be sensed by the surgical operator especially in transition sections in bones such as from a cortical to spongy bone and vice versa. Higher thrust force occurs on contact and in cortical bone, while lower values are obtained in spongy bone.Drill tip designed to impart force with distal end designed with cutting flutes to mate core diameter of the implant being driven to prepare hole of the drill diameter having provision to assemble with flexible shaft at proximal end for screwing the screw at degree. Drill bits make an entry for the fitment of the screw or implant

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