CDSCO UID MFG/MD/2023/000585_0a50b9a1d9e1bad2efbe699a05249f78_5685db224d4d21a80816fc6b171ae670

Bone Plate

Komal Health Care Pvt. Ltd.·Device Class Class C·India CDSCO·Brand: Plain and Locking

Registration details

UID: MFG/MD/2023/000585_0a50b9a1d9e1bad2efbe699a05249f78_5685db224d4d21a80816fc6b171ae670
Device class: Class C
Brand name: Plain and Locking
License holder: Komal Health Care Pvt. Ltd.
Approving authority: Central Drug Standards Control Organization, West Zone
Product information: The Zenium® Bone Plates are devices which are to be used as an aid to the treatment of certain types of fractures, fusions or osteotomies that lend themselves to the principle of plate and/or screw fixation. Like every type of orthopaedic implant, it cannot be assumed to be uniformly effective without risk. Use of these implants is not a substitute for normal tissue healing. The Zenium Bone Plates are designed to provide additional constraint of movement of a fractured, fused or osteotomized bone and are intended only as an aid to fix the fracture in place during the healing process. The Zenium Bone Plates are implants designed for fixation of certain fractures, fusions or osteotomies. Variation in implant size, diameter, and shape are intended to allow the implants to accommodate variations in patient size and sites of application. Zenium Bone Plates are manufactured from 316L medical grade implant quality stainless steel or from implantable medical grade titanium. Zenium Bone Plates should only be used with the appropriate size Zenium Bone Screws. Specific Indications: Specific fractures, fusions or osteotomies with configurations that would otherwise lend themselves to the general principle of bone plate fixation with this class of implants may be appropriate for use with this device. The following fracture, fusion or osteotomy configurations may be applicable for treatment using the Zenium Bone Plates and Screws: 1. Upper Extremities: Fractures, fusions or osteotomies from the distal phalanx to the clavicle amenable to plate and/or screw fixation where the size, shape, and location of the bone are appropriate for the specific implant(Plain and Locking) being used. 2. Lower Extremities: Fractures, fusions or osteotomies from the distal phalanx to the femur amenable to plate and/or screw fixation where the size, shape, and location of the bone are appropriate for the specific implant(Plain and Locking) being used