Oral and Cranio-maxillofacial Reconstructive Implants(TraumaOne System - India CDSCO Medical Device Registration

Oral and Cranio-maxillofacial Reconstructive Implants(TraumaOne System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000594_b2447118d8738aa3458431b942a67ffa_5c52783a7d17b634ddc164a4af6ef9a4. This device is marketed under the brand name Non-sterile. The license holder is Zimmer India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Oral and Cranio-maxillofacial Reconstructive Implants(TraumaOne System

UID: IMP/MD/2021/000594_b2447118d8738aa3458431b942a67ffa_5c52783a7d17b634ddc164a4af6ef9a4

Brand Name

Non-sterile

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

Screws)-For use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures. These devices are implantable bone plates and bone screws for oral, cranio-maxillofacial procedures including: 1. Fractures 2. Osteotomies 3. Reconstructive procedures 4. Revision procedures where other treatments or devices have failed. The Add-on condyle is indicated for use in cases of: 1. Temporary(Non-sterile) replacement of mandibular condylar head for patients with malignancy requiring resection of the mandibular condyle. 2. Benign neoplasms

Class C

Lockable Intramedullary Nails

Brand: Non-sterile

Stryker India Pvt. Ltd.,

Class C

Brand: Lorenz® Surgical Instruments

Class B