BONE WIRES, PINS & STAPLES - India CDSCO Medical Device Registration

BONE WIRES, PINS & STAPLES is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000156_24894138bb739e1710ee1c4b656ed992_81c6633a8fc2ff358e57d1c2a3f0e770. This device is marketed under the brand name ORTHOFLEX MEDISYS INDIA PVT. LTD.. The license holder is Orthoflex Medisys India Pvt Ltd, 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 WIRES, PINS & STAPLES

UID: MFG/MD/2021/000156_24894138bb739e1710ee1c4b656ed992_81c6633a8fc2ff358e57d1c2a3f0e770

Brand Name

ORTHOFLEX MEDISYS INDIA PVT. LTD.

License Holder

Orthoflex Medisys India Pvt Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Indications for Pins and Wires include Fixation of Bone Fractures, Bone Reconstructions, as guide pins for insertion of other implants and Implanted through the skin for traction applied to the skeletal system. Wires are used in the fixation of fractures in which loading is minimal. Wires are easier to bend, so, are supplemented with other immobilization devices where necessary. Pin or wire fixation is mostly used for fractures of the Phalanges, Metacarpals, Metatarsals, Proximal Humerus and Distal Humerus. Pins are used in fixation of fractures where minimal bone and soft tissue damage are involved. Pins provide provisional fixation leaving room for additional hardware placement. The provisional fixation is planned to avoid faulty permanent Fix tion. Depending on the diameter, pins may also be used as guidewires for cannulated screw fixation. Staples are used for fragment fixation, where inter-fragmental screw fixation is difficult. These are an effective internal fixation method and are widely used in foot and ankle surgery. The staples are also used in fixation of soft tissues to bone

Class C

BONE PLATES (ORTHOFLEX MEDISYS PVT LTD)

Brand: ORTHOFLEX MEDISYS INDIA PVT. LTD.

Orthoflex Medisys India Pvt Ltd

Class C

Brand: Wings Ortho

Class C