Australia TGA ARTG recordOrthopaedic fixation plate, non-biodegradable
Australia TGA ARTG Registered Device · Stable Orthopaedics Pty Ltd · Chetan Meditech Pvt Ltd · Class IIb · Started April 24, 2024
Good Name: Stable Orthopaedics Pty Ltd - Orthopaedic fixation plate, non-biodegradable
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- April 24, 2024
- Effective Date
- April 24, 2024
- Country
- India
- Address
- MD-04 Sanand-II GIDC Ahmedabad, Gujarat, 382 110
Osteotomy and Bone fixation plate used in conjunction with bone screws to provide fixation, intended for use in osteotomies, treatment of bone joint deformities, fixation of fracture, malalignment caused by injury or diseases, such as osteoarthritis of proximal tibia or distal tibia or Distal Femur. A/P (anterior/posterior) sloped osteotomy plates are used where tibial slope adjustments are needed. Osteotomy and Bone fixation plate intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle and osteopenic bone, and for glenohumeral joint by Latarjet/Coracoid Process Transfer in Glenoid rim damage/fracture.
Access comprehensive regulatory information for Orthopaedic fixation plate, non-biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Stable Orthopaedics Pty Ltd, manufactured by Chetan Meditech Pvt Ltd in India. The device registration started on April 24, 2024.
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