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MAXILLOFACIAL IMPLANTS {Titanium} - India CDSCO Medical Device Registration

MAXILLOFACIAL IMPLANTS {Titanium} is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000011_ed317f4db5c7adec1c0cf0705d488e0a_da854d1044b6875c16cff54481a46132. This device is marketed under the brand name Image. The license holder is Image Ortho Surgical Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
MAXILLOFACIAL IMPLANTS {Titanium}
UID: MFG/MD/2021/000011_ed317f4db5c7adec1c0cf0705d488e0a_da854d1044b6875c16cff54481a46132

Brand Name

Image

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Maxillofacial implants are indicated for use in fracture fixation, mandibular reconstruction and surgery involving osteotomies, orthognathic reconstruction or surgery, surgery related to dento-facial or facial cavity and trauma due to it. The intended use of these implants is to draw two or more aligned bone fragments together to facilitate healing Oral Maxillo Screws The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. There are three sets of style: cortical, cortex and cancellous (Image) sets. The screw recess is hexagon or star shaped to allow screw removal and insertion. These screw variants can be provided with locking compression threaded types as well as regular types. Locking bolts are used for the fixation of interlocking nails. Oral Maxillo Plate Bone Plate System consists of plates in various designs and size. Plates are provided in straight designs and various geometric configurations that are commonly used in traumatic and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws. They are named according to both anatomical positions and biomechanical functions of the plates. These plates are devices which are used to fasten the bones for the purpose of fixation of fractured bones. These plates can be distinguished in terms of their functions, i.e. the plate on which this is to be fixed

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